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DEPARTMENT OF
VETERANS AFFAIRS MEETING THE
PHARMACEUTICAL NEEDS OF VETERANS?
HEARING
BEFORE THE
SUBCOMMITTEE ON HEALTH
OF THE
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SUBCOMMITTEE ON HEALTH
MICHAEL H. MICHAUD, Maine, Chairman
HENRY E. BROWN, JR., South Carolina,
Ranking
CLIFF STEARNS, Florida
JERRY MORAN, Kansas
JOHN BOOZMAN, Arkansas
GUS M. BILIRAKIS, Florida
VERN BUCHANAN, Florida
Pursuant to clause 2(e)(4) of Rule XI of the Rules of the House, public hearing records
of the Committee on Veterans Affairs are also published in electronic form. The printed
hearing record remains the official version. Because electronic submissions are used to
prepare both printed and electronic versions of the hearing record, the process of converting
between various electronic formats may introduce unintentional errors or omissions. Such occurrences are inherent in the current publication process and should diminish as the process
is further refined.
ii
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CONTENTS
September 22, 2009
Page
OPENING STATEMENTS
Chairman Michael Michaud ...................................................................................
Prepared statement of Chairman Michaud ....................................................
Hon. Deborah L. Halvorson ....................................................................................
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31
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WITNESSES
U.S. Department of Health and Human Services, Solomon Iyasu, M.D., MPH,
Director, Division of Epidemiology, Office of Surveillance and Epidemiology,
Center for Drug Evaluation and Research, Food and Drug Administration ..
Prepared statement of Dr. Iyasu .....................................................................
U.S. Department of Veterans Affairs:
Belinda J. Finn, Assistant Inspector General for Audits and Evaluations,
Office of Inspector General ...........................................................................
Prepared statement of Ms. Finn ..............................................................
Michael A. Valentino, R.Ph., MHSA, Chief Consultant, Pharmacy Benefits Management Services, Veterans Health Administration ....................
Prepared statement of Mr. Valentino ......................................................
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53
18
58
23
61
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31
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39
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46
6
42
65
67
Jeanne Ireland, Assistant Commissioner for Legislation, Food and Drug Administration, U.S. Department of Health and Human Services, to Hon.
Michael H. Michaud, Chairman, Subcommittee on Health, Committee on
Veterans Affairs, letter dated November 6, 2009 .............................................
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Page
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(1)
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And finally, the recently released audit report from the Office of
the Inspector General raised concerns about the VAs management
of noncontrolled drugs and Consolidated Mail Outpatient Pharmacy
(CMOP) contracts. So we have panels here today of experts to help
us explore these issues. And I look forward to hearing from them
as well.
And I would now like to recognize Mrs. Halvorson if she has an
opening statement she would like to make.
[The prepared statement of Chairman Michaud appears on
p. 31.]
OPENING STATEMENT OF HON. DEBORAH L. HALVORSON
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STATEMENTS OF JACK HOADLEY, PH.D., RESEARCH PROFESSOR, HEALTH POLICY INSTITUTE, GEORGETOWN UNIVERSITY, WASHINGTON, DC; FRANK R. LICHTENBERG, PH.D.,
COURTNEY C. BROWN PROFESSOR OF BUSINESS, COLUMBIA
UNIVERSITY, NEW YORK, NY, AND RESEARCH ASSOCIATE,
NATIONAL BUREAU OF ECONOMIC RESEARCH; RICHARD F.
WEIDMAN, EXECUTIVE DIRECTOR FOR POLICY AND GOVERNMENT AFFAIRS, VIETNAM VETERANS OF AMERICA; AND
WILLIAM RAY BULLMAN, M.A.M., EXECUTIVE VICE PRESIDENT, NATIONAL COUNCIL ON PATIENT INFORMATION AND
EDUCATION, BETHESDA, MD
STATEMENT OF JACK HOADLEY, PH.D.
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difference in the two systems, the more integrated system where
physicians had the ability to prescribe from a formulary that they
have worked with and get exceptions made in what seems to us to
be a pretty readily done basis, that in the end, the veterans are
getting access, good access to drugs through the VA formulary.
So, with that, I will conclude my remarks.
[The prepared statement of Dr. Hoadley appears on p. 31.]
Mr. MICHAUD. Thank you very much, Dr. Hoadley.
Dr. Lichtenberg.
STATEMENT OF FRANK R. LICHTENBERG, PH.D.
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sorry are less than 15 years old, whereas the percentage that are
less than 15 years old for VA patients is 31 percent. So, in other
words, the drugs used in the VA health system during the period
1999 to 2002 were older than the drugs used in the rest of the U.S.
healthcare system. And in fact, the age of the drugs was, the relative gap was actually increasing. That is consistent with the hypothesis that implementation of the VA National Formulary beginning in 1997 reduced utilization of new drugs in the VA healthcare
system.
But what we presumably all care about is outcomes; is longevity,
disability, quality of life and so forth. I have done a number of
studies and some other economists have as well about the impact
of medical innovation and pharmaceutical innovation in particular
on longevity and other health outcomes. And in this paper, I
present some new estimates that suggest that the use of older
drugs in the VA system may have reduced the life expectancy or
mean age of death of VA patients by about 2 months. Now that
doesnt sound like a very significant number; however, there is
other evidence that suggests that peoples willingness to pay,
Americans willingness to pay to extend their lives is quite high, so
the per-patient value of that reduction in longevity may exceed
$25,000 per person.
I also use demographic data published by the VA to compute the
life expectancy of veterans both before and after the National Formulary was implemented. And here the picture is the following,
that starting in 1991, from 1991 to 1997, the life expectancy of
American veterans increased by about 3 years. However, it stopped
increasing after 1997 and maybe even declined a little bit, and that
coincides pretty precisely with the implementation of the VA Pharmacy Benefits Management System. So I think that that is evidence that needs to be considered further.
Thank you.
[The prepared statement of Dr. Lichtenberg appears on p. 39.]
Mr. MICHAUD. Thank you very much, Dr. Lichtenberg.
Mr. Weidman.
STATEMENT OF RICHARD F. WEIDMAN
Mr. WEIDMAN. Mr. Chairman, first of all, I want to thank you for
your leadership in holding this hearing today.
There really are two levels of issues here on the table. The first
is, and the one which our written statement primarily concerns
itself with, is access to getting new medications on the formulary
to begin with. We believe that it is inappropriate cost management
at the cost of proper clinical care. Many drugs are not making it
on. That is a clinical decision.
And that process by which things go on is a closed process. In
other words, it is not a transparent process. The advocates, the veterans service organizations, the medical societies do not have the
opportunity to comment. There is no recipient advisory group that
has a chance to have the say for what the veterans and their families have to say about this; what does the medical community in
general have to say about this?
Cutting to the chase, what we propose and urge you to consider
is moving to introduce legislation that will make the VA formulary
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mirror that at U.S. Department of Defense (DoD). The DoD formulary, everything, as soon as it is FDA approved, as soon as practical, which is usually a short period of time, it goes on the DoD
formulary or the TRICARE formulary.
The veterans on active duty suddenly shouldnt feel the pinch
that those who are no longer on active duty, either because they
retired or because of longevity or because they have ended their
term of service because they got wounded, should have the access
to the full range of drugs that those on active duty should have.
That is also incidentally an open and transparent process. It is
warned. There are public meetings. There are minutes, and there
are a number of recommendations, which actually Secretary
Shinseki can take even without such legislation, but we would encourage you to move ahead and to develop comprehensive legislation in association with your friends over at the House Armed
Services Committee, who are thoroughly familiar with that process,
and move forward to do it.
One of the fallacies of limiting the formulary is that we are saving money. We would argue that it is penny wise and pound foolish. Oftentimes the lack of the proper medication at the proper
time because it wasnt on the formulary leads to all kinds of
healthcare impact that results in sicker patients and episodes that
did not have to happen.
I will use, just as one example, diabetes. And you may recall that
a patient advocate leadership summit last year with veterans service organizations came together in Washington, and we focused on
four diseases. One of those was diabetes, and what stunned all of
us in the veterans service organization community is that, in fiscal
year 2006, two-thirds of the cost of care for diabetes went into
acute inpatient stays.
Let me say that again: Two-thirds of the total cost of treating the
1.2 million diabetics who go to the VA for their healthcare was in
inpatient treatment services. What that means is, when you have
to put somebody in the hospital who is under a physicians care
who has diabetes is that you failed. You have failed big time.
And as a result of that, that is very expensive. It causes secondary conditions, which leads to amputations of limbs. It causes
all kinds of secondary conditions which are then themselves service-connected compensable. This is particularly true for Vietnam
veterans, where those of us who served in Vietnam where diabetes
is in fact service-connected presumptive. That is one level.
I dont have much time to comment on the second level except
to say that the overall management, people are generally happy
with the timeliness of the medications, assuming that they can get
the medications that they need off of the formulary. But by changing what goes on to the formulary, you have competent people to
manage the system.
But I cannot stress too strongly that while they say that unions
sometimes mirror the worst excesses of the business industry in
which they organize, in this case, the VA has mirrored the worst
in past decade or 15 years of the pharmaceutical industry, which
lost its way for a time and seems to be finding its way again, where
they forgot they were in the health business. That is the business
they are in, in helping people get well, stay well as long as pos-
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sible, and they are not in the cost-containment or selling the most
widgets or having the highest cost reduction on the case of the government side or their cost margin and profit margin on the case of
the private industry side.
Mr. Chairman, once again, thank you very much for holding this
hearing today. And I would be happy to answer any questions sir.
[The prepared statement of Mr. Weidman appears on p. 42.]
Mr. MICHAUD. Thank you very much.
Mr. Bullman.
STATEMENT OF WILLIAM RAY BULLMAN, M.A.M.
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deficiency virus drugs, within, until 1 year after it has been approved by the FDA. So there is a general predisposition against
listing new drugs on the formulary. I think that that policy continues and that it is potentially having adverse effects on the
healthcare of veterans.
Mr. MICHAUD. Are you familiar at all with the DoD process in
getting drugs on the formulary?
Dr. LICHTENBERG. I am afraid that I am not.
Mr. MICHAUD. Thank you.
Mr. Weidman, you brought up a very good suggestion about looking at the DoD formulary and the process that they go through,
and reading your testimony I assume that that process is more
transparent than the VA process.
That being said, can you tell me what process a veteran or someone would have to go through to get a physician to prescribe a drug
that is not on the formulary? Is it a cumbersome process? Have you
heard of any complaints about counselors getting supervised or reprimanded by the supervisor if they go off the formulary?
Mr. WEIDMAN. The answer is, it is extraordinarily difficult. It
takes a lot of time. It is a cumbersome process and deliberately so.
And even incidentally for some expensive drugs that are on the formulary, they will put them on fourth or fifth screen back and make
it difficult for people to access the more expensive drugs at some
stations. And nobody has really looked at that, and nobody is policing that.
The issue over trying to get medications that are not on the formulary, that is always VAs rejoinder, is that the formulary is fine
because people can get anything that is not on the formulary when
it is clinically indicated.
But that is just flat not true as a practical matter. We hear from
clinicians all the time both in physiological and in neuropsychiatry
that if they take things and make recommendations for drugs that
are not on the formulary, not only does it take an enormous
amount of time when they are under pressure to see patients, faceto-face encounters with patients, but also they get spoken to. They
get spoken to enough times, and they dont, and they are down the
road; it is as simple as that.
And it is clearly a conscious policy. Part of the problem is the
way in which we have misapplied comparative effectiveness within
the VA so that it becomes a race to the bottom, so that the pharmacy is measured about cost avoidance below the national mean
average. Well, what happens if you have all 152 stations doing
that, of trying to get below the mean average? Well, it continues
to go down. And that is the wrong measure. What chief pharmacists and all pharmacists ought to be measured against is how
much did you contribute to the overall wellness of the individual
patients at this medical center and avoid inpatient stays and keep
the patient more healthy and contributing for those of working age
to the overall economy. Those should be the questions we should
be asking. And it is possible to develop metrics that way. People
are going to do what you measure them on. It is as simple as that.
And we need to change the way in which we think about pharmacy
at the VA, and we need to change the way in which VA measures
it internally.
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And one last thing, if I may mention on that issue, you asked
about the IOM. We do need to revisit the IOM because what the
IOM said is, there are no good metrics inside the VA to measure
what is going on and to analyze it from the outside. And that is
still the case today. And if they have measurements, they are refusing to share it with anybody. And once again, stuff that happens
in the back room is where bad stuff happens. We are a democracy.
This should be done out in the sunshine. And the way in which the
DoD process happens is it is a totally public process with an advisory committee and with minutes and people can attend, and it is
warned in the Federal Register, et cetera, et cetera. And we need
the same kind of process with the VA and that a lot of the problems, we believe, if we adopt the DoD policy on formulary will come
to, will go away.
Just one last thing. The theory is that clinical stuff is taken into
account at the VA. And with all due respect, the way you mentioned before about clinical evidence and it is collaborative decision
of the doctors; well, it is not. It is not. The green-eyed boys always
trump. The cost always trumps clinical evidence when it comes to
putting things on the VA formulary. So that, even when they are
looking through the molecular entity process that they have set up,
they can go all the way through that and have strong evidence
about cost effectiveness as well as the efficacy of the drug, and then
the formulary people, the pharmacy people can still veto it just on
the basis of cost and impact on the pharmacy. And this is just not
right.
Clinical decisions need to predominate throughout the VA. And
if we cant do that, then we are certainly not delivering care second
to none. One could argue that then it is care second to all. And that
is not the way we should be doing business, and frankly, we have
so many wonderful clinicians in the VA, if we can fix the system
and let them do their job, we will be care second to none.
Mr. MICHAUD. Thank you very much.
Mr. Weidman, you mentioned the DoD formulary. Since there are
more drugs on that formulary than on the VA formulary, have you
heard complaints where a servicemember may be using a certain
drug that is on the DoD formulary, moves to the VA system, and
is no longer able to get that medication?
Mr. WEIDMAN. I have, and also our friends in modern warfare
have told me many of those problems as well where people are kind
of stunned because, particularly those that come out of Walter
Reed, and Walter Reed still has some problems particularly with
medical boards and with case management, but it is overall, you
know, a fabulous facility, and all of a sudden, bang, they hit the
VA system back home in Michigan or Togus or wherever the case
may be, and one of the things they hit is the formulary and difficulties, particularly those who have traumatic brain injury (TBI) and
seizures. It is very difficult because a lot of those things are not
on the formulary, and therefore, their doctors have to go through
circumlocutions. They can get it. Their VA doctors are willing to do
it, but it is not right that they should jump through hoops.
Those are the kinds of things that should automatically be presumed to be in, and we need to balance the system so we go back
to clinical input at every step of the way and achieve a balance be-
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tween cost and best clinical care, and currently, we would argue
that cost is trumped all the way down the line on this one.
Mr. MICHAUD. Thank you very much.
Mrs. Halvorson.
Mrs. HALVORSON. Thank you, Mr. Chairman, and thank you all
for being here.
I have got several questions, and I guess I am not sure where
to start.
First of all, again, the IOM study, actually is in quotes, where
it says that it has a responsive process in place where assuring access to medically necessary prescription drugs. Sooh, for exceptions to the formulary. So that actually is said in the study that
was done almost a decade ago, so obviously we need to look. How
do you feel about the fact that that is actually written in this IOM
study that obviously needs to be taken a look at?
Now, Mr. Weidman, you have said that we need to take a look
at that again. So it is one thing to say we need to take a look at
it and another thing to do it. So what would you suggest, because
you say most of these things are done behind closed doors, how do
you profess that we take this out and do it in the open? Do another
study first? What would be your idea?
Mr. WEIDMAN. Well, the IOM study, by the time you get it going
is going to take a year and a half, and I would suggest that many
of the things in the recommendation section of my statement, Congresswoman, are things that the Secretary could start doing right
now to open up this process while the Congress considers whether
or not to change the statute and mirror that which is used by DoD
and TRICARE and TRICARE For Life, that mandating or just requesting with this Secretary, I think you can just request to him
that he contract with the IOM to do another study.
Now the way in which that RFP or that request for a proposal
is drawn, that contract with the Institute of Medicine is something
that, frankly, the committee should have direct input in on as well
as the veterans service organizations and other advocates because
sometimes those contracts are designed to make sure that you dont
get at what is the part of the original intent.
And so that would be one way of doing it.
Second I think it would be useful to have the U.S. Government
Accountability Office (GAO) in the short term look at some of the
areas that we know are of concern. As an example, Alzheimers
drugs, has it had a tremendous negative impact on people not having the latest Alzheimers drugs? As many of you know, some of
our older veterans, even some of the older Vietnam veterans, but
certainly the Korean and World War II vets are subject to Alzheimers. Nobody has come up with a cure for Alzheimers yet, and
we are not suggesting that there is. All you can do is slow it down.
So when you slow down those new medications that are coming on
the market and have come on the market in the last 3, 4, 5 years
from being available to those World War II and Korean veterans,
they are never going to get better after they haveby the time VA
puts it on the formulary, if indeed they ever do under existing circumstances.
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the VA because they, typically what happens is the Vietnam vet
who is in-country, finds out that it is service-connected presumptive or he or she retires or loses their job, and then they turn to
the VA for their healthcare, and then they discover that the diabetes medication they have been on for 5 years or 3 years, you cant
get at VA, and it is very hard to get those exceptions.
It took us, I think it was 8 months, 9 months, pressing hard to
get the long-lasting insulins added last year to the VA formulary,
and we had to go with the white paper. And it was through the
good offices of this Committee that it finally got added on to the
formulary, because people couldnt get it, virtually, by going off-formulary through the process.
Mr. SNYDER. Thank you.
Thank you, Mr. Chairman.
Mr. MICHAUD. Thank you.
Once again, I would like to thank each of you for your testimony
today. There might be some additional questions that we will ask
in writing. Hopefully you will respond in a timely manner. I really
appreciate each of your testimonies here this afternoon, so thank
you.
I would like to ask the second panel to come forward. While they
are coming forward, we have Solomon Iyasu, who is a Director of
a Division within the FDA, U.S. Department of Health and Human
Services (HHS). We also have Belinda Finn who is accompanied by
Irene Barnett, who are both from the VA Office of Inspector General.
I want to thank all three of you for coming here this afternoon
to give your testimony, and we will start off with the good doctor.
STATEMENTS OF SOLOMON IYASU, M.D., MPH, DIRECTOR, DIVISION OF EPIDEMIOLOGY, OFFICE OF SURVEILLANCE AND
EPIDEMIOLOGY, CENTER FOR DRUG EVALUATION AND RESEARCH, FOOD AND DRUG ADMINISTRATION, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES; BELINDA J. FINN,
ASSISTANT INSPECTOR GENERAL FOR AUDITS AND EVALUATIONS, OFFICE OF INSPECTOR GENERAL, U.S. DEPARTMENT
OF VETERANS AFFAIRS; ACCOMPANIED BY IRENE BARNETT,
PH.D., AUDIT MANAGER, BEDFORD OFFICE FOR AUDITS AND
EVALUATIONS, OFFICE OF INSPECTOR GENERAL, U.S. DEPARTMENT OF VETERANS AFFAIRS
STATEMENT OF SOLOMON IYASU, M.D., MPH
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fairs. It is currently in the process of being renewed for another
year.
In September 2007, Congress passed the Food and Drug Administration Amendments Act, which included new resources for medical product safety that requires the HHS Secretary to establish a
post-market risk identification and analysis system to link and
analyze healthcare data from multiple sources. The Sentinel Initiative is FDAs response to this mandate. Its goal is to build and implement a new active surveillance system that will eventually use
electronic health information to monitor the safety of all FDA-regulated products.
The Sentinel Initiative is a long-term effort that must proceed in
stages, and this effort is well under way. The FDA is collaborating
with the Federal and private sectors in various activities that
would inform the development of this system.
In December 2008, the FDA held a public meeting on the Sentinel Initiative to obtain input from stakeholders about the structure, function, and scope of the project. The Director for the Center
for Medication Safety of the Department of Veterans Affairs was
among the participants at this day-long meeting, presenting on the
issue of risk communication.
After the initial step of creating the Sentinel System, the FDA
is initiating various pilot efforts to further the science of medical
product surveillance. One of these pilots, known as Mini-Sentinel
II, would include our Federal partners. We look forward to the VAs
participation in this effort. The effort involves creating a distributed system that will focus on developing methodologies to obtain
more information on emerging drug safety issues. The Sentinel
System will augment the Agencys current post-market surveillance
tools to strengthen FDAs ability to ensure that safe and effective
new drugs are available to the public, and that the risks of marketed drugs are well understood.
The FDA has a critical role in the detection and management of
safety issues that are identified after a drug is approved, including
a critical role in communicating information to the public. Our goal
is to make the most up-to-date drug safety information available to
the public in a timely manner so that healthcare professionals and
patients can consider the information when making decisions about
medical treatment. Our ability to fulfill our mission is enhanced by
our partnerships with patients, physicians, pharmacists, industry,
State regulators and other partners like Veterans Affairs. Together
we can help ensure the safe use of marketed drugs by providing
the best possible information to the American public.
Once again, thank you for the opportunity to testify to the Subcommittee today.
[The prepared statement of Dr. Iyasu appears on p. 53.]
STATEMENT OF BELINDA J. FINN
Ms. FINN. Chairman Michaud and Members of the Subcommittee, thank you for the opportunity to be here today and discuss VHAs accountability for noncontrolled drugs. We have recently issued two audit reports that address systemic weaknesses
at VHAs medical facilities and consolidated mail outpatient pharmacies, commonly known as the CMOPs.
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STATEMENT MICHAEL A. VALENTINO, R.PH., MHSA, CHIEF
CONSULTANT, PHARMACY BENEFITS MANAGEMENT SERVICES, VETERANS HEALTH ADMINISTRATION, U.S. DEPARTMENT OF VETERANS AFFAIRS; ACCOMPANIED BY CHESTER
B. GOOD, M.D., MPH, CHAIR, VETERANS AFFAIRS MEDICAL
ADVISORY PANEL, VETERANS HEALTH ADMINISTRATION
U.S. DEPARTMENT OF VETERANS AFFAIRS; AND PAUL
TIBBITS, M.D., DEPUTY CHIEF INFORMATION OFFICER FOR
ENTERPRISE DEVELOPMENT, OFFICE OF INFORMATION
AND TECHNOLOGY, U.S. DEPARTMENT OF VETERANS AFFAIRS
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So we made the decision because evidencethe evidence supported use of Lucentis, and even though we were getting calls to
use Avastin instead, because it was quite a bit cheaper, because
the evidence supportedin the literature supportedand that is
our approach, to live and die by the evidence, what we think will
best help the veteran. And in this case we thought that by far the
more expensive drug for the same indication was what was in the
best interest of the veteran.
So this decision made several years ago, which stands today, was
to mandate use of Lucentis rather than the far, far cheaper
Avastin.
Mr. MICHAUD. My very last question. Why did the VA allow the
directive on drug accountability software to lapse in 2003?
Mr. VALENTINO. We have incorporated a lot of our directives into
handbooks that are based on themes, National Formulary handbooks, different kinds of handbooks.
We looked at that particular requirement, and we found that although it may seem like it really adds to the security, in fact all
it does is tell you about those drugs that you are looking at, as we
heard from the OIG. If folks tend to know where you are looking,
they go other places.
So we had fully anticipated that we would have the perpetual inventory process in place by now, And so we didnt feel that that requirement should be continued in policy.
Mr. MICHAUD. Thank you.
Any additional questions?
Once again, Mr. Valentino, I want to thank you and Dr. Tibbits
and Dr. Good for coming today, as well as the previous two panels
with us. It has been very helpful, and we really appreciate it and
look forward to working with you to try to address some of the concerns that I heard.
We will adjourn the Subcommittee hearing.
[Whereupon, at 3:45 p.m., the Subcommittee was adjourned.]
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A P P E N D I X
Prepared Statement of Hon. Michael H. Michaud,
Chairman, Subcommittee on Health
The Subcommittee on Health will now come to order. I would like to thank everyone for attending this hearing.
The goal of todays hearing is to determine whether the VA is meeting the pharmaceutical needs of our veterans. We are conducting this hearing because of the
concerns that I have heard from our veterans about proper access to non-formulary
prescription drugs, concerns about adverse drug interactions and patient safety, and
recent reports by the Office of Inspector General citing the need to better manage
certain aspects of the VAs pharmacy benefits program.
When properly designed and implemented, formularies can promote drug therapy
that is rational, clinically appropriate, safe, and cost-effective. However, patient care
may be compromised if a formulary system is not developed and administered so
that individuals can access the drugs that they need. I have heard from veterans
who have voiced their frustration with the VA national formulary as being too restrictive to the point that accessing appropriate drugs is a barrier. Some veterans
have pointed to a flawed, subjective system for securing non-formulary drugs. For
example, a veteran who is denied access to a non-formulary drug at one VA medical
center may be approved in another medical center, which suggests that the decision
may not be based entirely on clinical factors.
I also have concerns about patient safety and whether we are doing enough to
prevent adverse drug events. Among the medication errors leading to adverse drug
events are missed doses, duplicate therapy, drug to drug interaction, inadequate
monitoring, and preparation error. For example, what is the VA doing to prevent
adverse drug events and are they coordinating well with the FDA? What steps is
the VA taking to ensure that veterans do not accidentally take their prescribed medicine in wrong doses or do not forget to take their medicine at the right times? Also,
how does the VA make sure that they catch potentially adverse drug interactions
when veterans get their prescriptions filled both at the VA and at private pharmacies?
Finally, the recently released audit reports from the Office of Inspector General
raise concerns about the VAs management of non-controlled drugs and the Consolidated Mail Outpatient Pharmacy (CMOP) contract. Efficient management of the
CMOP contract is critical because almost 80 percent of all VA pharmaceuticals are
dispensed using the CMOP.
We have our panels of expert witnesses to help us explore these issues today. I
look forward to hearing their testimonies.
f
Prepared Statement of Jack Hoadley, Ph.D., Research Professor,
Health Policy Institute, Georgetown University, Washington, DC
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A report prepared in December 2006 for the Pharmaceutical Research and Manufacturers of America (PhRMA) concluded that the application of a VA-style formulary process to the Medicare prescription drug program would significantly reduce physician and patient choice of drugs, and that a reduction in choice of prescription drugs could be of special concern for the Medicare population.1 In an April
2007 memo, Greg DAngelo of the Heritage Foundation wrote that if Congress fixes
prices in Medicare and establishes a restrictive national formulary, the program
would be less responsive to the diverse and ever-changing needs of beneficiaries.2
As a result of those statements, my colleagues and I decided to shed further light
on these issues by conducting an objective comparison of the VA National Formulary to formularies used by Part D plans.
We examined a sample of 160 commonly prescribed drugs and compared their status on the VA National Formulary to comparable unrestricted coverage for a variety
of Medicare Part D plans. In general, we found that the VA listed fewer drugs on
formulary, but our analysis of off-formulary prescribing at the VA suggests that this
does not translate into less access to the drugs than exists under Medicare Part D.
Background
Formularies were used by veterans medical centers as early as 1955 to help manage pharmacy inventories. In 1995, the VA took steps to consolidate its bargaining
power with drug makers and thus reduce spending. It combined the formularies of
local VA medical centers to create a single formulary in each of 21 Veterans Integrated Service Networks (VISNs). Two years later, it implemented a national formulary, and by 2007 the VA had completed the process of phasing out the VISN
drug lists, making the national formulary the definitive and only VA drug list.3
The VA National Formulary functions somewhat differently than most
formularies maintained by private organizations. Since the VA is an integrated system meaning that veterans go to VA facilities to see VA doctors and fill prescriptions at a VA formulary the VA has a great deal of leverage to promote the use
of a single formulary within its facilities and patient pool. This distinguishes the
VA formulary from those used by most private insurers. In most private plans, a
drugs formulary status might not be known by a physician when a prescription is
written, but instead only determined at the point of sale by the pharmacist, when
the patient brings a prescription to be filled at the local pharmacy. In those cases,
the prescribing physician has no particular relationship with the insurer or health
plan. The VA system is more like group and staff model HMOs such as Kaiser
Permanente, where the formulary is viewed as a clinical tool to be used by physicians, rather than an enforcement tool of the plan applied at the pharmacy.
The VA National Formulary is managed by practicing VA physicians and regional
formulary managers and takes into account safety, efficacy, and cost in deciding
what drugs to list on the formulary. As part of the process, VA clinicians have an
opportunity to provide input on the decisions, which helps to create a sense of buyin for them. In addition, VA physicians and pharmacists prepare comprehensive
written reviews that summarize recent published research on the safety and efficacy
of drugs in specific drug classes. These reviews may be used to make recommendations on a drugs status within the formulary. For example, a 2003 review of oral
bisphosphonates (typically used to treat osteoporosis) concluded that since Fosamax
and Actonel produce similar results . . . the VHA should consider these two drugs
equivalent clinically, and choose one for use based on best value.4
The VA considers some classes closed, that is, drugs in that class are only covered if they are listed on the formulary. Generally, only a few drugs in a closed
class are listed on the national formulary. The VA justifies the exclusion of others
on the grounds that they are therapeutically interchangeable equivalent in terms
of efficacy, safety and outcomes to the drugs on the formulary. The VA can then
obtain lower prices for on-formulary drugs through competitive contracts by commit-
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ting to use them whenever clinically appropriate.5 Most often, these are classes
where multiple brand-name drugs are available, but few or no generic alternatives.
Drugs in other classes may have restrictions, meaning that physicians are encouraged to prescribe certain preferred drugs in that class over others.6 Such restrictions are used both to create leverage in negotiating prices and to restrict inappropriate use of certain drugs.
According to the VHA, drugs not listed on the national formulary may be prescribed through a non-formulary request process designed to ensure timely, evidence-based decisions. Non-formulary drugs may be approved for use by a patient
if:
1. Formulary agents are contraindicated;
2. Formulary agents have caused adverse reactions;
3. All formulary alternatives have demonstrated therapeutic failure;
4. No formulary alternative exists; or
5. The patient has previously responded to a non-formulary agent and risk is associated with a change to a formulary agent.
Through this process, drugs not listed on the VA formulary can be prescribed. An
informal survey by the VA pharmacy benefit manager in 1998 found that 88 percent of waiver requests [for non-formulary medications] were approved.7 Nevertheless, VA formulary compliance is very high. The VA estimates that overall use of
drugs not on the formulary is about 5 percent. This high compliance, especially for
the closed classes, is aided by the sense of buy-in by VA clinicians and the reliance
on clinical evidence as a key component of the decision-making process. Adherence
for a closed class sometimes reaches 90 percent within 3 months of a formulary
change and over 98 percent within 6 months.8
Several studies over the past decade have asked whether the VA National Formulary too strictly limits the prescription drugs available to veterans. After a 1999
report by the House Committee on Appropriations raised such concerns, a mandated
report by the Institute of Medicine, released in 2000, concluded that the VA National Formulary is not overly restrictive, and the limited available evidence suggests that it has probably meaningfully reduced drug expenditures without demonstrable adverse effects on quality. The reviewers also found, however, that the National Formulary lacked essential systems to assure that new drugs are expeditiously reviewed and that more needed to be done to ensure that a responsive
process for assuring access to medically necessary exceptions to the formulary is
consistently in place.9
In 1999 and 2000, the VA commissioned two independent surveys of VA prescribers perceptions of the VA National Formulary. The first survey identified a
subset of physicians who believed this formulary was more restrictive than most in
the private sector or that it impinged on providing quality care to their patients.
But nearly two-thirds thought they were able to prescribe needed drugs and that
their patients could obtain nonformulary drugs when needed.10 Respondents to the
second survey also indicated general satisfaction with the formulary and agreed that
it was important for containing costs and ensuring good value. Although they reported that roughly 90 percent of waiver requests for off-formulary drugs were approved, about one-third of the physicians indicated that approvals took 3 days or
longer.11 In 2001 the Government Accountability Office told the Congress that prescribers reported that the national formulary generally contains the drugs their patients need or, when necessary, prescribers can usually get non-formulary drugs.12
In a 2005 report, economist Frank Lichtenberg concluded that the VA was tardy
in its addition of newly FDA-approved drugs to the VHA formulary, and noted that
5 GAO, VA Drug Formulary: Better Oversight is Required, but Veterans Are Getting Needed
Drugs.
6 Institute of Medicine, Description and Analysis of the VA National Formulary (Washington:
National Academic Press, June 2000).
7 IOM, Description and Analysis of the VA National Formulary.
8 Michael Valentino, Overview of the VA Pharmacy Benefits Management Strategic Health
Care Group (PBM), presentation to the American Enterprise Institute, 19 January 2007.
9 IOM, Description and Analysis of the VA National Formulary.
10 Peter A. Glassman et al., Physician Perceptions of a National Formulary, American Journal of Managed Care 7:3 (March 2001), pp. 241251.
11 Peter A. Glassman et al., Physician Satisfaction with Formulary Policies: Is It Access to
Formulary or Nonformulary Drugs that Matters Most? American Journal of Managed Care 10:3
(March 2004), pp. 209216.
12 VA Drug Formulary: Better Oversight is Required, but Veterans are Getting Needed
Drugs.
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only 19 percent of the drugs approved since 2000 were on the VHA formulary.13
Lichtenberg attributed the use of older drugs in the VA formulary to a reduction
in veterans mean age of death, by 2.04 months. But Lichtenbergs report was rebutted by the VAs Michael Valentino in a 2007 presentation.14 He offered evidence
that veterans experienced greater life expectancies at birth than other populations.
Arguing that newer is not always better, he pointed out that many new drugs
are actually me too drugs that are essentially the same as and not necessarily
more effective than treatments already on the market. Valentino also noted that
23 new drugs (including some that Lichtenberg lists as not covered by the VA) were
taken off the market for safety reasons between 1980 and 2005, and concluded,
what is the rationale for exposing patients to drugs with unknown risks, when
there is little or no clinical advantage? Valentino insisted that the VA reviews all
new molecular entities for consideration for national formulary listing in a timely
fashion, and that it based its decisions on cost and efficacy data.
Comparing VA and Medicare Part D Plan Formularies
To compare the VA National Formulary with those offered by the Medicare Part
D prescription drug plans, my colleagues and I focused on a pre-selected sample of
160 drugs representing more than half the prescription volume for Medicare beneficiaries. The sample includes all drugs in 14 drug classes, as well as other commonly prescribed drugs, and has nearly equal numbers of generic (n=76) and brandname (n=84) medications.15 For Medicare, our analysis covers 47 standalone prescription drug plans offered on a national or near-national basis in 2007, as well
as two formularies offered in different regions by a group model HMO participating
in the Medicare Advantage program. We considered the number of plans that listed
a drug, whether the drug was placed on a generic, preferred, or specialty tier, and
whether the drug was restricted through any utilization management tools (prior
authorization, step therapy, or quantity limits). For the VA, the analysis considered
whether a drug was listed on formulary and the yearly volume of prescriptions written for that drug.16
A simple count of the 160 sample drugs on the VA formulary suggests that it lists
fewer drugs (82 drugs) than any of the national or near-national Part D plans (median number of drugs listed = 136; minimum = 99). However, there are key reasons
that make this simple accounting misleading. First, veterans have unrestricted access to all drugs listed on the VA formulary and access to additional drugs if they
seek authorization. By contrast, Part D plans include drugs on their formularies
that may only be available to beneficiaries subject to utilization restrictions, such
as prior authorization, step therapy, or quantity limits. In the VA system, patients
only need to seek prior authorization or undergo step therapy for drugs not listed
on the VA National Formulary.
The TNF Inhibitor class, which includes three expensive specialty drugs primarily
used for treating rheumatoid arthritis (Enbrel, Humira, and Remicade), illustrates
this dynamic. Neither the VA nor the median Part D plan covers any of these drugs
outright. In the VA, the drugs are considered off formulary, but they are available
when patients or their doctors request authorization. Most Medicare drug plans list
these three drugs on formulary, but require prior authorization before the drug is
actually covered. In these two situations, patients face a similar level of restricted
access, but the formulary status is different.
Second, many Part D plans list drugs on a non-preferred tier with a higher level
of cost sharing. This system creates a financial incentive for beneficiaries to adhere
to their plans formulary, even when their doctor may not know which drugs are
preferred or not preferred. By contrast, the VA does not use tiers; cost sharing for
any drug is limited to $8 for a months supply for those patients subject to the co-
13 Frank R. Lichtenberg, Older Drugs, Shorter Lives? An Examination of the Health Effects
of the Veterans Health Administration Formulary, Center for Medical Progress at the Manhattan Institute, October 2005.
14 Michael Valentino, Overview of the VA Pharmacy Benefits Management Strategic Health
Care Group.
15 For more details on our sample of drugs, see Jack Hoadley et al., An In-Depth Examination
of Formularies and Other Features of Medicare Drug Plans, Henry J. Kaiser Family Foundation, April 2006, and Jack Hoadley et al., Benefit Design and Formularies of Medicare Drug
Plans: A Comparison of 2006 and 2007 Offerings A First Look, Henry J. Kaiser Family Foundation, November 2006.
16 Data on whether a drug is on the VA National Formulary and its restrictions were obtained
from the VAs Web site (January 2007 version). Information on the prescription volume was provided to the authors by the VA. The VAs formulary lists all drugs by chemical name; thus we
assumed that when both a generic and a brand-name version of a particular chemical exist, only
the generic version is listed.
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payment. Because VA doctors use only the VA formulary, they can become familiar
with its coverage; financial incentives are not needed to steer use.
Because of these system differences, it is most relevant to compare the VAs formulary to the list of drugs that are on a preferred tier in a Part D plans formulary,
without designations for either prior authorization or step therapy.17 For the national and near-national plans, the median number of unrestricted on-formulary
drugs is 104, compared to 136 when restricted drugs are included. By this criterion
the typical Medicare plan formulary comes closer to the 82 drugs listed on the VA
National Formulary (Table 1).
Table 1. Number of Drugs with Unrestricted Coverage, VA Formulary and
Selected Medicare Plans, 2007
All Drugs
(N=160)
Generic
Drugs
(N=76)
Brand
Drugs
(N=84)
82
56
26
104*
72
37
On VA Formulary
Median, 47 national Part D plans
Minimum, 47 national Part D plans
80*
48
20
149
76
73
112
75
37
98
70
28
Humana/Complete
121
76
45
Humana/Enhanced
121
76
45
Humana/Standard
149
76
73
117
76
41
118
74
44
Silverscript (Caremark)
102
63
39
97
73
24
94
74
20
77
45
32
79
50
29
Medicare
Advantage
* Median and minimum for all drugs are measured directly and not the sum of the brands and generics
values.
* Note: Unrestricted coverage is defined as coverage on a preferred tier with no prior authorization or step
therapy requirements.
One view of the difference between the VAs formulary and those used by Part
D plans is how they treat the generic drugs in our sample (Table 1). The typical
Part D plan lists over 90 percent of generic drugs, and several of the ten most popular plans list all of the generics we studied. By contrast, the VA lists only 56 of
76 sample generic drugs. This reflects the different perspective of those designing
these formularies. The VA chooses preferred drugs among competing generics based
on a combination of clinical evidence and price. By contrast, Part D plans have incentives to list on formulary most or all of the generics in a particular class. Lacking
17 When a drug has a quantity limit, we do not treat that as a restriction. Some plans designate large numbers of drugs with quantity limits, apparently to restrict the dispensing of prescriptions of more than 30 days.
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any close relationships with prescribing physicians, they must rely on enforcement
at the pharmacy to encourage use of one particular generic over another. Doing so
risks alienating their enrollees for minimal financial gain and may discourage enrollment if drugs are listed as off-formulary on the Medicares online Drug Plan
Finder.
As noted above, the approach to formulary design in an integrated health plan
is more like the VA system than other Part D plans. It is not surprising, therefore,
that Kaiser Permanente formularies were similar in scope to the VA formulary
(Table 1). In both of its California regions, Kaiser Permanente listed slightly fewer
sample drugs on formulary (77 and 79) than the VA National Formulary. Like the
VA, the Kaiser plans are more likely than other Part D plans to omit generic drugs
from their formularies.
Comparisons at the Drug Class Level
Comparisons between the VA National Formulary and the Part D plan
formularies vary considerably by drug class (Table 2). One reason for the variation
is that some drug classes (e.g. beta blockers) consist mostly of generic drugs. Most
Part D plans list nearly all generics on formulary, whereas the VA is more likely
to omit generic drugs from its formulary for such classes. Specific program rules also
affect the comparisons. For example, Part D plans include more anti-depressants at
least partly because Medicare guidelines require that nearly all unique anti-depressants be listed on formulary, although the guidelines do not require that coverage
be unrestricted.
Table 2. Formulary Listings by Class, VA and Part D Formularies, 2007
Drugs
Studied
Drug Class
VA
National
Formulary
Median, 47
National
Plans*
KP
Northern
CA
KP
Southern
CA
Anti-Dementia Agents
Anti-Depressants
30
18
23
24
24
Beta Blockers
15
14
Cholesterol Agents
18
11
Diabetes Agents
16
12
Hormonal Agents
12
Renin-Angiotensin
18
10
27
20
22
14
12
160
82
104
77
79
TNF Inhibitors
Other Common Drugs
TOTAL, SELECTED DRUGS
*Drugs listed on a generic or preferred tier and without prior authorization or step therapy restrictions. Note
that the median value for the total is not the total of the class medians.
The pattern is similar for the Kaiser Permanente formularies, but the details are
different. Kaisers formularies, for example, list fewer drugs in categories such as
anti-cholesterol agents or the renin-angiotensin drugs used to treat hypertension.
But Kaiser lists more anti-depressants than the typical Part D plan. Kaiser also
lists more drugs without restriction in the TNF inhibitor class than either the VA
or the typical Part D plan, because they do not require prior authorization for these
drugs.
The Class of Cholesterol Drugs
The contrasting ways that formularies work in the VA compared to the standalone Part D plans can be illustrated with the class of cholesterol drugs. The VAs
coverage of cholesterol agents has been criticized because the formulary does not list
some popular anti-cholesterol drugs such as Crestor and Lipitor, while the majority
of national Part D plans list them without restrictions.18 As shown in Table 2, the
typical Part D plan lists 11 of the anti-cholesterol agents in our sample, whereas
the VA lists 7 drugs and Kaiser Permanente lists just 4 in one region and 5 in another.
18 Deroy Murdock, VA Program No Model for Helping Americans Buy Medications, Deseret
News, 31 December 2006.
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Whenever possible, the VA suggests that a high potency formulary statin should
be the first-line treatment prescribed for the patient. If he or she fails to meet clinical goals on that drug, physicians are advised to consider a second-line therapy
(such as niacin or non-formulary Zetia) or a switch to a non-formulary statin, such
as Lipitor.19 These guidelines mean that non-preferred or even non-formulary drugs
are recommended and accessible to veterans, and they may be prescribed in greater
numbers than their on-formulary or unrestricted counterparts. In fact, as Table 3
shows, there is more utilization of Zetia, considered a second-line therapy not listed
on formulary, than the two on-formulary drugs in the Bile Acid Sequestrants group.
Similarly, prescribing of Lipitor, another second-line therapy that is not on formulary, is higher than for Lescol, one of the on-formulary statins.20
Table 3. Formulary Listing of Cholesterol Agents, 2007
Generic Name
On VA
Formulary?
# of 47
Part D
plans
with unrestricted
coverage
CHOLESTRYAMINE
CHOLESTRYAMINE
46
Welchol
COLESVELAM
20
4,714
Colestid
COLESTIPOL
18
168,976
EZETIMIBE
36
369,783
Tricor
FENOFIBRATE
37
130,181
GEMFIBROZIL
GEMFIBROZIL
47
1,771,658
NIACIN
41
1,258,306
OMEGA-3 ACID
13
827
Lipitor
ATORVASTATIN
34
711,138
Lescol
FLUVASTATIN
500,954
Altoprev ER
LOVASTATIN
12
LOVASTATIN
LOVASTATIN
47
1,424,081
Mevacor
LOVASTATIN
376,688
Pravachol
PRAVASTATIN
56,255
PRAVASTATIN
PRAVASTATIN
33
**
Crestor
ROSUVASTATIN
33
144,341
Drug*
VA Utilization FY
2006
Nicotinic Acid
Niaspan ER
Omega-3 Fatty Acids
Omacor
Statins
19 Ezetimibe (Zetia) for Nonformulary Use, VHA Pharmacy Benefits Management Strategic
Healthcare Group and the Medical Advisory Panel, updated January 2007.
20 After this analysis was completed, changes were made to the VA National Formularys
treatment of statins in response to FDA approval of generic versions of Pravachol and Zocor.
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Table 3. Formulary Listing of Cholesterol Agents, 2007Continued
Drug*
Generic Name
On VA
Formulary?
# of 47
Part D
plans
with unrestricted
coverage
VA Utilization FY
2006
SIMVASTATIN
SIMVASTATIN
45
**
Zocor
SIMVASTATIN
16,487,514
Comparative effectiveness reviews of clinical evidence have led to a similar conclusion to that of the VA. The Consumer Reports Best Buy Drugs report, based on
research by the Drug Effectiveness Review Project, recommends use of one of three
generic statins, with Lipitor as an alternative for patients who have had a heart
attack or acute coronary syndrome together with highly elevated LDL.21 Among the
47 national and near-national Part D plans, 34 list Lipitor and 33 list Crestor, while
nearly all list generic drugs lovastatin and simvastatin.
Another factor that affects the formulary comparisons is the Medicare Programs
guidance requiring that Part D plans list on formulary at least one drug in each
subgroup of cholesterol drugs, although plans may use coverage restrictions. The VA
has no such mandatory coverage requirement. Because Zetia and Omacor are the
only drugs in their subgroups, Part D plans must list them, whereas the VA formulary does not. Nevertheless, shown in Table 3, not all Part D plans have unrestricted coverage of these drugs. The VA, which recommends Zetia as a second-line
therapy, filled about 370,000 prescriptions for the drug.
Conclusions
An objective comparison of unrestricted coverage by Medicare Part D plans to the
VA National Formulary shows that the VA formulary is modestly smaller than the
typical Part D plan formulary and about the same as formularies used by Kaiser
Permanente. But formulary size is not the same as access to drugs. This small gap
largely reflects the difference between integrated and non-integrated health systems
and the resulting approaches to ensuring access.
The VA National Formulary is closely tied to its prescribing system. Like a staffmodel or group-model HMO, physicians in the VA system participate in creating the
formulary and commit to prescribing from it when it meets their patients needs.
Patients in both of these integrated healthcare systems are less likely than other
types of Part D or private health plans to receive a prescription, only to be told later
that it is not covered or covered at a much higher price than a more preferred drug.
The incentive in integrated systems is for physicians to prescribe from the formulary when they can, but it is a relatively straightforward process to obtain authorization for any drug that is not on the formulary. By contrast, physicians treating patients in non-integrated systems face a variety of formularies for the different
plans in which their patients are enrolled, and they are unlikely to prescribe according to each patients formulary unless the plan or patient points out which drugs
are preferred. It is essential when making comparisons with regard to access to
drugs between the VA and other plans to keep these differences in mind.
A full comparison of access to prescription drugs between the VA system and
other health systems would require more extensive studies, such as surveys or clinical outcome studies. Nevertheless, this comparison of Medicare Part D plan
formularies to the VA formulary lends support to the conclusion that veterans maintain good access to prescription drugs through the VA National Formulary.
f
21
http://www.bestbuydrugs.org/drugreportlDRlStatins.shtml
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Prepared Statement of Frank R. Lichtenberg, Ph.D.,
Courtney C. Brown Professor of Business,
Columbia University, New York, NY, and Research Associate,
National Bureau of Economic Research
Access to new drugs in the Veterans Health Administration
Access to medical innovations longevity and health
Research that I and other economists have performed indicates that access to
medical innovationsnew drugs, medical procedures, and devicesis
one of the most important determinants of longevity and health.
Four years ago I performed a study that examined access to new drugs under
the pharmacy benefits management system of the Veterans Health Administration. Since 1997, the VA National Formulary has played a key role in that system.
The fractions of drugs approved in the 1950s, 1960s, 1970s, and 1980s that
were on the 2005 VA National Formulary were almost identical: 5253 percent.
However, only 38 percent of the drugs approved in the 1990s, and 19 percent of the drugs approved since 2000, were on the VA National Formulary. Only 22 percent (17) of the 77 priority-review drugs approved
since 1997 were on the 2005 National Formulary. (Figure 1)
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The drugs used in the VA health system during 19992002 were older than the
drugs used in the rest of the U.S. healthcare system. For example, the percentages of VA and non-VA prescriptions for drugs less than 5 years old were 5.6
percent and 8.6 percent, respectively, and the percentages for drugs less than
fifteen years old were 31.4 percent and 39.0 percent. (Figure 2)
40
The percent of drugs less than 10 years old increased by 1.4 percentage points
per year in the non-VA sector, and by 0.6 percentage points per year in the VA
sector. The percent of drugs less than 15 years old increased by 1.9 percentage
points per year in the non-VA sector, and had virtually no increase in the VA
sector.
These estimates are consistent with the hypothesis that implementation
of the VA National Formulary beginning in 1997 reduced utilization of
new drugs in the VA healthcare system.
Older drugs reduced longevity, higher utilization of hospitals and
nursing homes
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The life expectancy at birth of all U.S. males increased after as well as before
1997, although the rate of growth declined by about a third. (Figure 4)
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Implementation of the VA National Formulary is likely to have increased utilization of hospitals and nursing homes. I estimate that if the
age of the drugs used by the Medicare population were increased to match that
used in the VA health system, the increase in hospital, home healthcare, officevisit, and nursing-home expenditure among the elderly would be about $5.1 billion per year.
42
Bibliography
Lichtenberg, Frank R., Older Drugs, Shorter Lives? An Examination of the
Health Effects of the Veterans Health Administration Formulary, Medical
Progress Report No. 2, October 2005, http://www.manhattan-institute.org/
html/mprl02.htm
Lichtenberg, Frank R., Paul Grootendorst, Marc Van Audenrode, Dominick
Latremouille-Viau, and Patrick Lefebvre, The impact of drug vintage on patient survival: a patient-level analysis using Quebecs provincial health plan
data, Value in Health 12 (6), 2009, pp. 847856.
Lichtenberg, Frank R., Have newer cardiovascular drugs reduced hospitalization? Evidence from longitudinal country-level data on 20 OECD countries,
19952003, Health Economics 18 (5), 2009, pp. 519534.
Lichtenberg, Frank R., and Gautier Duflos, Pharmaceutical innovation and the
longevity of Australians: a first look, Advances in Health Economics and
Health Services Research 19, 2008, pp. 95117.
Lichtenberg, Frank R., The Impact of New Drugs on U.S. Longevity and Medical Expenditure, 19902003,American Economic Review 97 (2), May 2007, pp.
438443.
Lichtenberg, Frank R., Pharmaceutical Innovation and U.S. Cancer Survival,
19922003: Evidence from Linked SEERMEDSTAT Data, Forum for Health
Economics & Policy: Vol. 10: Iss. 1 (Frontiers in Health Policy Research), Article 1.
http://www.bepress.com/fhep/10/1/1
f
Prepared Statement of Richard F. Weidman, Executive Director for
Policy and Government Affairs, Vietnam Veterans of America
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management of the formulary system used by the VHA. The National Formulary
lacks essential systems to assure that new drugs are expeditiously reviewed for inclusion, and that a responsive process for assuring access to medically necessary exceptions to the formulary is consistently in place system-wide, that therapeutic
interchange is accomplished in a flexible and consistent way, sensitive to patient
risk, across the far-flung VHA system, and that views of critical constituencies of
both providers and patients are represented in the management of the National Formulary . . .
Perhaps most troubling, the (IOM) Committee found a dearth of information to
evaluate the full impact of the National Formulary on veterans health and satisfaction, and on the VHA. That remains the case today because the VA process takes
place in the back room, out of public view.
Since the time of the IOM Study of the VA National Formulary, the VA Formulary and Formulary process has only grown more restrictive and little has been
done to address the concerns expressed in the IOM study. Individual Veterans Integrated Services Network (VISN) formularies have been eliminated in favor of only
a consolidated VA National Formulary.
The VA Formulary process involves internal Pharmacy and Medical expertise
through its own Medical Advisory Panel (MAP) and is cross connected to the Department of Defense Pharmacoeconomic Center (DoD PEC) and Indian Health but
does not have outside professional or beneficiary interest represented, such as the
Veteran Service Organizations, or professional pharmacy and pharmacists organizations, or advocacy groups like the American Diabetes Association. Appropriate national level professional organizations that would best represent the patient as relates to safe and appropriate medication use, could include representation from professional organizations such as the American Pharmacists Association (APhA),
American Society of Health-System Pharmacists (ASHP), Academy of Managed Care
Pharmacy (AMCP), and American Society of Consultant Pharmacists (ASCP), as
well as other professional medical societies.
The lack of transparency and insular nature of the VA formulary decision-making
process is problematic and leaves unanswered questions about access to care, chronic disease care, criteria use in reaching decisions (e.g., costs versus long-term clinical
effectiveness). VA should publish specific drug decision-making criteria, including
the therapeutic category review schedule, decision-making process, Pharmacy and
Therapeutics Committee and Medical Advisory Panel members, meeting schedules,
and discussions of specific decisions. In addition, the public should have an opportunity to submit information to the VA Pharmacy and Therapeutics Committee in
preparation for each decision meeting.
The VA formulary decision-making process should also include a VA Pharmacy
Beneficiary Advisory Committee as does the Department of Defense TRICARE Uniform Formulary process. For example, the Department of Defense/TRICARE publically announces in advance its therapeutic class review schedule, the specific drugs
for review, and the criteria for comparing different drugs. The DoD
Pharmacoeconomic Center (PEC) receives pricing and clinical data from the public
including pharmaceutical companies which are considered by the DoD Pharmacy
and Therapeutics (P&T) Committee. The DoD publishes on its Web site (http://
www.pec.ha.osd.mil/) the recommendation of the P&T Committee, the rationale, and
summary of the data considered.
These recommendations are then reviewed by a DoD Beneficiary Advisory Panel
(BAP; http://www.tricare.mil/pharmacy/bap/) composed of non-government beneficiary, professional and patient advocacy organization representatives, TRICARE
contractors, and others. These meetings are also announced in advance, open to the
public, and the results are published on the PEC Web site. The P&T Committee and
the BAP recommendations are then forwarded to the Director of the TRICARE Management Activity for final decision. In most cases, newly FDA-approved prescription
medications are available from TRICARE network pharmacies and the mail-order
pharmacy program shortly after they become commercially available. Furthermore,
the public has the opportunity for input at each step in the decision-making process,
and it is transparent.
Conversely, the Department of Veterans Affairs National Formulary decisionmaking process lacks transparency and opportunity for public input. This results in
major disadvantages for VA patients and the quality of VA healthcare. It can be argued that the overly restrictive VA formulary as it stands today is significantly distorting the practice of medicine at the VA, to the detriment of the health of veterans
who seek care there.
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Recommendations:
Optimally, the Congress will pass a law mandating an open and transparent process that is modeled on the law for DoD/TRICARE, and is at least as open and transparent a process (if not more so) than the DoD procedure. The DoD process automatically includes all medications approved by the FDA. It is up to managers to justify restricting access to a medication by removing it from the formulary, and this
has to play out in a public setting with significant input from advocacy groups, medical societies, and other interested parties. VA should do no less for our veterans
once they take off the uniform.
Short of this much needed comprehensive overhaul or transformation of the VA
formulary, or perhaps while the Committee is working to draft and secure passage
of this legislation, VVA recommends the following steps be taken immediately by
Secretary Shinseki:
Change the performance evaluation criteria for Chief pharmacists to measure his
or her contribution toward the overall wellness of the patients at a particular Medical Center. There are currently no such metrics in place, but they can be developed
and these contributions measured, just like almost anything else. (Currently the
pharmacists are rewarded by how much cost avoidance they can achieve in comparison with the national mean. This, of course, means that it is a race to the bottom. It is a testimony to the professionalism and commitment to good medicine by
the pharmacists that, given the way the system is set up, with the emphasis on cost
containment/cost reduction, that so many veterans do get the right medication in
the right amount when they need it.)
The VA P&T Committee meeting schedule, therapeutic categories to be reviewed,
and review criteria should be publically announced well in advance of P&T meetings.
The VA P&T Committee should establish a procedure to accept and consider public input for these Formulary meetings.
The VA P&T Committee should publish its recommendations made in the last
decade with rationale for the conclusions and recommendations of the Committee.
The Secretary of Veterans Affairs should establish a Beneficiary Advisory Committee (BAC) of representatives from a representative sampling of major veterans,
patient advocacy, and healthcare professional groups with the responsibility and authority to make recommendations on the decisions of the VA P&T Committee including addition, deletions, clinical use criteria, and preauthorization requirements
on drugs on the VA National Formulary.
Meetings of the VA Formulary Beneficiary Advisory Committee should be open to
the public and the minutes and considerations of all BAC recommendations published on the VA P&T Committee Web site in a timely manner.
Like the DoD Beneficiary Advisory Panel, the VA Formulary Beneficiary Advisory
Committee should include at least 1215 members and have the opportunity to
make Recommendations prior to final decision on VA National Formulary changes
and other pharmaceutical issues. At least two of the following organizations should
be included in the membership of the VA Beneficiary Advisory Committee, the
American Pharmacists Association (APhA), American Society of Health-System
Pharmacists (ASHP), Academy of Managed Care Pharmacy (AMCP), and American
Society of Consultant Pharmacists (ASCP).
The VA Formulary Beneficiary Advisory Committee should have the authority to
recommend to the VA drug categories and new drugs to be reviewed, changes to the
criteria for use, clinical guidelines, restrictions on use, etc.
The Veterans Health Administration should be required to consider the recommendations of the VA Formulary Beneficiary Advisory Committee prior to making final decisions on VA Uniform Formulary including addition, deletions, clinical
use criteria, and preauthorization requirements.
Conclusion
The Secretary of Veterans Affairs could do some, all, or most of the nine steps
outlined here above within the scope of his authority. However, there will be stiff
resistance on the part of VHA officials who like the status quo. All too often, some
seemingly do not believe that they should be answerable to anyone outside of that
closed system, much less individual veterans or veterans service organizations.
These folks will have millions of reasons not to change, and perhaps so will some
at the Office of Management & Budget (OMB). They also have their own constituencies around Washington who will tell the Secretary that it is just too expensive
to provide expensive drugs to veterans. These individuals have had years of practice
in push back to prevent any significant change being accomplished without legislation passing the Congress.
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It is our belief that the time is right for this Subcommittee to take the lead in
creating a statutorily directed formulary that is inclusive as a starting point, that
is totally transparent, and that has to take into account input from stakeholders,
both medical professionals and advocates outside of government. The VA continues
to have great bargaining power to secure the best possible prices on each and
every medication, and we believe that the private sector will be reasonable in this
regard. In any case, it is impossible to say Care Second to None until we clean
up this major problem with the VA formulary.
If we are going to assist the President to achieve transformation of the VA for
the 21st century, then there is no better place to start than ensuring full transparency in the VA formulary, and a presumption of inclusion of all FDA approved
medications. And, for that, we need bi-partisan legislation and the strong leadership
from this Subcommittee on this issue.
Thank you for your leadership in holding this hearing on a crucial subject, Mr.
Chairman. I will be pleased to answer any questions, and look forward to working
with you and your colleagues to greatly improve this vital service to veterans.
f
Prepared Statement of William Ray Bullman, M.A.M.,
Executive Vice President, National Council on Patient Information
and Education, Bethesda, MD
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spectrum of organizations serving the public health through educational and advocacy programs; 2) to empower consumers to be more informed about and active in
decisions affecting their use of medicines; and 3) to be a catalyst and convener for
the development of new, useful, and scientifically accurate information about medicine use that is disseminated in multiple formats to a wide range of audiences.
What makes NCPIE unique, besides its long-term focus on the appropriate use
of medicines, is the depth and breadth of its national coalition of nearly 100 organizations committed to providing patients with useful and appropriate medicine information. The NCPIE coalition includes: consumer organizations; patient advocacy
groups, and voluntary health agencies; organizations representing healthcare professionals and health educators; schools of pharmacy; State and Federal Government
agencies; health-related trade associations; national and international private sector
companies including pharmaceutical manufacturers, patient information/database
companies, and managed care organizations.
NCPIE is based in Bethesda, Maryland. J. Leonard Lichtenfeld, M.D., representing the American Cancer Society, currently serves as NCPIEs Chairperson.
Patient Medication Safety Issues/Current and Ongoing NCPIE Programs
NCPIE is one of the original patient safety organizations, addressing safe and appropriate medicine use through the identification, development, and dissemination
of educational messages and resources to promote safe and appropriate medicine
use. NCPIE also convenes and participates in ongoing and ad-hoc external collaborations and issues-driven project partnerships, striving to address a wide range of potential medication safety (safe use) issues, as described below:
Safety Issues Related to Communicating Risk via Written Consumer Medicine InformationNCPIE, in 1996, at the request of then HHS Secretary
Shalala, participated in the development of a 10Year Action Plan for the Provision of Useful Prescription Medicine Information. The Action Plan, which
included criteria for quality improvements for both clinical content and the design,
layout, and readability of written medicine information leaflets conveyed by community pharmacies with every retail prescription, sunset in December 2006. The Food
and Drug Administration as the lead agency responsible for assessing to what extent Action Plan quality improvements were achieved by the private sector during
this 10-year period, is conducting a 2-day workshop later this week to obtain key
stakeholder input on proposed new prototypes for such useful written information
and to seek input on a research agenda to ensure consumer input on the development, design, and testing of such written information. NCPIE is participating in the
workshop as a reactor panelist.
Safety Issues Related to Medication NonadherenceAlthough the challenge
of poor adherence has been discussed and debated for at least three decades, these
problems have, until recently, generally been overlooked as a major healthcare priority. NCPIE has since 1995 called for national action to address this major public
health problem that has recently been estimated to cost the U.S. economy over $290
billion annuallyor 13 percent of total healthcare expenditures (New England
Health Care Institute, July 2009). Consider:
Nearly 3/4 of Americans report they dont take their medications as directed;
One in three never fill their prescriptions;
For common chronic conditions such as diabetes and hypertension, proper adherence averages only 5065 percent;
Three69 percent of medication-related hospital admissions are linked to poor
adherence.
Failure to follow medication regimes is especially harmful to people with chronic
health conditions. When those with chronic conditions fail to follow their medication
regimen, they risk decreased productivity, a lesser quality of life, a more rapid progression of their condition, complications, hospitalization, and even death. Employers are seeing billions of dollars lost to chronic condition-related absenteeism and
presenteeism (when employees report for work, but do not function at full capacity).
It is estimated that diabetes accounts for 120 million work days lost every year to
presenteeism.
In 1995, NCPIE released the referenced report, Prescription Medicine Compliance: A Review of the Baseline of Knowledge, which outlined the health
consequences of nonadherence and defined key factors contributing to poor medication adherence. The report included an overview of strategies to enhance adherence,
along with implementation tools and materials.
In August 2007, NCPIE released its second report, Enhancing Prescription
Medicine Adherence: A National Action Plan. This referenced report was released as a renewed nationwide call to action for improving medication adherence
through patient information and education, health professional intervention, ex-
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panded research, and supportive government policies. The report includes 10 recommendations for action that cross-cut the continuum of carefrom diagnosis
through treatment and follow-up patient care and monitoring. The report is available for download at www.talkaboutrx.org.
1. Elevate patient adherence as a critical healthcare issue.
2. Agree on a common adherence terminology that will unite all stakeholders.
3. Create a public/private partnership to mount a unified national education
campaign to make patient adherence a national health priority.
4. Establish a multidisciplinary approach to compliance education and management.
5. Immediately implement professional training and increase the funding for
professional education on patient medication adherence.
6. Address the barriers to patient adherence for patients with low health literacy.
7. Create the means to share information about best practices in adherence education and management.
8. Develop a curriculum on medication adherence for use in medical schools and
allied healthcare institutions.
9. Seek regulatory changes to remove roadblocks for adherence assistance programs.
10. Increase the Federal budget and stimulate rigorous research on medication
adherence.
Safety Issues Related to Prevention of Medication Abuse Among Teens
While the use of tobacco, alcohol and illicit drugs is declining overall, a new threat
is emerging; more teens are abusing prescription drugs than any illicit drug, except
marijuana. The misuse and abuse of prescription medicationsthe very same drugs
used to legitimately relieve pain, and treat conditions like anxiety, depression, sleep
disorders, or ADHD in some peopleis a growing and under-recognized problem
that puts young lives at risk.
One in 5 teens (or 4.5 million) has deliberately abused these drugs.
One in 3 teens surveyed says there is nothing wrong when using prescription
drugs every once and a while.
Every day, 2,500 youth (1217) abuse a prescription pain reliever for the very
first time.
NCPIE, with contract support from the Substance Abuse and Mental Health Services Administration (SAMHSA), and input from a project advisory team of over a
dozen national organizations involved in drug abuse prevention and teen health, has
developed two collaborative educational campaigns to promote prevention of prescription medicine abuse among teenagers:
Not Worth the RiskEven If Its Legal, consisting of English and Spanish
language television and radio spots, a newspaper article (English and Spanish
distributions) and two educational brochures, one targeting teens and one targeting parents. All of the campaign elements are posted for viewing on
www.talkaboutrx.org.
Maximizing Your Role as a Teen Influencer: What You Can Do To Help
Prevent Teen Prescription Drug Abuse,turn-key educational workshop
materials (Power Point presentation with presenters notes and a comprehensive Presenters Guide) to equip teen influencers (e.g., parents, teachers, school
administrators, coaches, community leaders, physicians and pharmacists) with
the knowledge and skills to communicate with teens and help curb prescription
drug abuse.
NCPIE has begun development of a third resource, an online Tool Kit for
Curbing Prescription Medicine Abuse on Americas College Campuses,
in October 2009.
Safety Issues Related to Proper Disposal of PharmaceuticalsProper disposal of unused medications has become a visible and sensitive public health and
environmental issue. Goals of proper disposal programs include: 1) Prevent environmental exposures and impacts from improper pharmaceutical disposal, especially to
the aquatic ecosystem; 2) Minimize accidental overdoses by people, pets and wildlife;
3) Limit opportunities for drug-related crime and subsequent abuse; 4) Provide a
safe alternative to drug stockpiling in homes; 5) Preclude outdated drug donations;
and 6) Facilitate pharmacoeconomic assessments of waste and prescriptions, insurance, and reimbursement and dispensing policies and practices.
NCPIE distributes a handout for consumers on proper disposal entitled, Tips on
Safe
Storage
and
Disposal
of
Your
Prescription
Medicines.
(www.talkaboutrx.org). NCPIE is also a collaborative partner and participant in
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The Safe Medicine Disposal for Maine. NCPIE is represented on the project advisory team for this statewide pilot disposal program developed in Maine with grant
support from the U.S. Environmental Protection Agency (EPA). The program provides a safe and anonymous method of drug disposal for Maine residents and is the
first of its kind in the country. For additional information see: http://
www.safemeddisposal.com/.
Safety Issues Related to the Prevention of Medication ErrorsNCPIE is
a member of the National Coordinating Council for Medication Error Reporting and
Prevention (NCC MERP), a coalition of over two dozen leading national healthcare
organizations who work collaboratively to address the interdisciplinary causes of
medication errors and to promote the safe use of medications. The U.S. Pharmacopeia spearheaded the formation of NCC MERP and is a founding member and
Secretariat for NCC MERP. The Department of Veterans Affairs is also a member
of NCC MERP. Currently, 14 NCC MERP Recommendations reside on the NCC
MERP Web site at: http://www.nccmerp.org/councilRecs.html. Select sample titles include: Recommendations to Enhance Accuracy of Prescription Writing; Recommendations for Health Care Organizations to Reduce Medication Errors Associated with the Label, Labeling, and Packaging of Pharmaceutical (Drug) Products
and Related Devices; and Reducing Medication Errors Associated with At-risk Behaviors by Healthcare Professionals.
Safety Issues Related to Safe and Appropriate Use of Acetaminophen
ProductsNCPIE is currently participating in two coalitions (Maryland Acetaminophen Coalition and the American Pharmacists Multi-Stakeholder Coalition) addressing the safe use of OTC and prescription medicines containing the active ingredient acetaminophen. Acetaminophen is sold under several brand names and is also
available in over 600 cough and cold products, sleep aids, and prescription pain relievers.
The wide spread utilization of acetaminophen by patients may increase the incidence and prevalence of misuse, which can lead to severe healthcare outcomes.
Many cases of overdose are caused by patients inadvertently taking more than the
current recommended dose of a particular product, or by taking more than one product containing acetaminophen (e.g., an over-the-counter product and a prescription
drug containing acetaminophen).
Safety Issues Related to Older Adults and Medication Use/MisuseNCPIE,
in 2007, developed and launched The Medication Use Safety Training for Seniors TM program (MUST for Seniors TM). This turn-key, online educational program
for older adult medicine users, caregivers, and community-based programs that address older adult health and wellness includes a complete menu of video vignettes,
Power Point presentations with accompanying scripts and a range of supporting
educational
handouts
for
individuals
or
group
participants.
See:
www.mustforseniors.org.
The following patient medication safety issues were first described by NCPIE in
a forward-looking October 1987 referenced report, Priorities and Approaches for Improving Prescription Medicine Use by Older Americans.
The report summarized the problem of improper medication use among older adults,
its consequences, and factors contributing to the problem; identified priorities for resolving factors leading to medication misuse; and suggested practical approaches to
program developers for taking action in the following key priority areas: 1) Poor
Communication Between Older Patients And Health Professionals; 2) Polypharmacy
(the use of multiple medicines); 3) Multiple Health Care Providers 4) Altered Drug
Action and Response With Advancing Age; 5) Inability To Take The Medication As
Prescribed, and 6) Deliberate Nonadherence.
Safety Issues Related to Children and Improper Medicine UseIn 1989
NCPIE produced a referenced report entitled, Children and Americas Other
Drug Problem: Guidelines for Improving Prescription Medicine Use Among
Children and Teenagers. Key findings from the report included the finding that
improper medicine use among children is a widespread problem. Adolescents are
even more likely not to take medicine as prescribed than children under age 13.
Four types of improper medicine misuse commonly occur: 1) Stopping a medicine too
soon; 2) Not taking enough of a medicine; 3) Refusing to take a medicine; 4) Taking
too much of a medicine. The consequences of such improper medicine use are serious: 1) Dangerous health outcomes; 2) Inadvertent treatment errors; 3) Life-threatening adverse effects; 4) Unpleasant side effects; 5) Unnecessary diagnostic and
treatment costs; and 6) Greater risk of accidental poisoning.
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Select Best Practices, Programs or Policies that NCPIE Member Organizations Employ to Enhance Medication and Patient Safety
NCPIE is pleased to share best practices, programs, or policies that select member
organizations employ to enhance safe and appropriate medicine use and patient
safety. The following represents only a partial list of such members work products:
American Pharmacists Association
American Society of Health System Pharmacists
Academy of Managed Care Pharmacy
Health Resources and Services Administration, Office of Pharmacy Affairs
Institute of Safe Medication Use (ISMP)
Pharmacy Coalition Work Product
American Pharmacists Association (APhA)
Medication Therapy Management (MTM) CentralAPhA Web content;
comprehensive information about MTM including links to:
MTM Certificate Program
MTM Services Continuing Education Programs
APhA MTM Digest
100 MTM Tips for the Pharmacist
http://www.pharmacist.com/AM/Template.cfm?Section=MTM&Template=/
TaggedPage/TaggedPageDisplay.cfm&TPLID=87&ContentID=19154
Pharmacist Clinical Services Improve Health Care Quality, Lower
Health Care CostsPotential Medication Therapy Management Impact: $30
Billion in Savings
Information presented by APhA to demonstrate possible savings if pharmacist
clinical services were more widely available for the following diseases: Diabetes,
Cardiovascular Disease, and Asthma. Includes the following data from the Department of Veterans Affairs (VA): By extrapolating the average salary data for a pharmacist, the VA expects to see an annual $368,000 in savings from each pharmacist
by providing clinical pharmacy services. (Schumock OT, Butler MC, Meek PD,
Vermeulen LC, Arondeker BV, Bauman JL. Evidence of the Economic Benefit of
Clinical Pharmacy Services: 19962000 Pharmacotherapy 2003; 23(1):113132)
American Society of Health-System Pharmacists (ASHP)
ASHP supports all pharmacists being able to play a leadership role in medicationuse safety. In larger hospitals, a dedicated position is necessary to oversee the management of medication safety initiatives. This new position has emerged to provide
leadership in medication-use quality and safety: the Medication Safety Officer
(MSO). The MSO is a practitioner who serves as an authoritative leader within the
organization on safe medication use. While an MSO can be a nurse or physician,
this role is usually filled by a pharmacist or pharmacy manager in the Department
of Pharmacy. To become an MSO, requirements include formal training in medication safety and quality best practices. Pharmacists who choose to specialize in medication-use safety undergo 10 years of educational training, including an accredited
postdoctoral residency training program. Job responsibilities of an MSO include, but
are not limited to, the following:
1. Managing information on patients and medication
2. Overseeing processes for prescribing and monitoring use of medication
3. Optimizing communication methods to minimize risk for errors
4. Minimizing potential for error in medication labeling, packaging, and nomenclature
5. Standardizing administration, dosing, and storage of medication
6. Overseeing preparation, distribution, dispensing, and administration of medication
7. Evaluating and oversee acquisition, use, and monitoring of medication delivery devices
8. Maintaining safe environmental conditions for patients and staff
9. Ensuring healthcare staff competence, education, and proficiency
10. Ensuring patient education
11. Maintaining quality processes and oversee risk management
12. Ensuring legal and regulatory compliance
13. Serving as a liaison to the public for the organization and management
14. Evaluating integration of technology, automation, and clinical information
systems
15. Promoting Best Practices for safe medication use
16. Collaborating with other healthcare disciplines and hospital leadership to coordinate system-wide medication safety initiatives.
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ASHP compiles its policy positions, statements, guidelines, technical assistance
bulletins, therapeutic position statements, therapeutic guidelines, and selected
ASHP-endorsed documents in ASHPs Best Practices for Hospital & Health-System Pharmacy. This compilation is updated annually, and provides guidance and
direction to ASHP members and pharmacy practitioners and to other audiences who
affect pharmacy practice.
Academy of Managed Care Pharmacy (AMCP)
The Framework for Quality Drug Therapy (http://www.fmcpnet.org/
index.cfm?p=132D8447)
This uniquely designed self-assessment tool is intended to be used by individual
pharmacists and other healthcare practitioners and by organizations of virtually any
size, from a physicians office to a large corporate health plan. The interactive tool
provides individual practitioners and organizations with an online step-by-step process to identify, evaluate and improve upon specific task, skills and functions that
contribute to effective medication therapy management. By answering a series of
questions contained in the interactive self-assessment tool, the program helps identify drug therapy management areas ripe for improvement. The program then populates any one of three action plan templates chosen by the user. The action plan
template provides a format for defining measurable goals, assigning responsibilities,
identifying available resources, and tracking progress, thus beginning a continuous
quality improvement process.
Health Resources and Services Administration, Office of Pharmacy Affairs
Patient Safety and Clinical Pharmacy Services Collaborative Change Package,
(PSCS; version 11, August 1, 2008). The Patient Safety and Clinical Pharmacy
Services Collaborative Change Package, is organized into strategies. Each strategy
includes change concepts, each of which is accompanied by action items (e.g., assess
organizational needs for quality . . .). The Change Package also denotes links to current corresponding national initiatives, helpful tools and resources, and definitions
relevant to the proposed material. The following is one illustrative strategy:
Strategies to Achieve Accountability for Results
IV. Safe Medication Use Systems: Develop and operate by safe medication-use
practices
Key Change Concepts for Improved Patient Safety and Clinical Pharmacy
Systems
J.
Systematically introduce and institutionalize safe medication-use practices
and monitoring procedures.
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2004 Self-assessment
2000 Self-assessment
Antithrombotic Therapy
Bar Coding Assessment
Community/Ambulatory Pharmacy
Physician Practices
ISMP Medication Safety Self Assessment for Automated Dispensing Cabinets
Pharmacy Coalition Work Product
1. Principles of a Sound Drug Formulary System
A coalition of national organizations representing healthcare professionals, government, and business leaders formed a working group (Including the Department
of Veterans Affairs. See Appendix III) to develop a set of principles specifying the
essential components that contribute to a sound drug formulary system. The Coalition was formed in September 1999 in response to the widespread use of drug
formularies in both inpatient and outpatient settings and the lack of understanding
about formularies among the public. The passage of Federal legislation providing a
prescription drug benefit for Medicare beneficiaries also brought increased attention
to the appropriate role and management of drug formulary systems within drug
benefit programs. This document contains Guiding Principles that the Coalition
believes must be present for a drug formulary system to appropriately serve the patients it covers. See: http://www.amcp.org/amcp.ark?p=AA8CD7EC
How The NCPIE Coalition Works to Meet its Mission
NCPIE works to meet its mission to stimulate and improve communication of information on the appropriate use of medicines to consumers and healthcare professionals, through both in-house development and implementation of educational
products or programs and through convening or participating in collaborative programs with both member and non-member organizations. Examples of both approaches include:
Dedicated/Recurring Event of Observance
In October 1986, NCPIE conducted its first annual Talk About Prescriptions Month. The purpose of Talk About Prescriptions Month (TAP
Month) is to help ensure that safe and appropriate medicine use through highquality medicine communication is positioned as an important public health
issue. TAP Month also provides NCPIE a regularly-scheduled platform for announcing new educational products, programs or services to promote its organizational mission. The theme for NCPIEs upcoming, 24th annual TAP Month,
October 2009 is, Talk About Prescriptions: Communication is Key.
Establish Key Partnerships
In-house development, January 2002 launch, and ongoing implementation of
Be MedWise to Promote Safe Use of Over-the-Counter Medicines
(www.bemedwise.org). NCPIE conceptualized this ongoing, Web-based public
education campaign and invited the Food and Drug Administration and the
American Pharmacists Association to participate in its launch at a national
Press Club media briefing. Dr. Richard Carmona, M.D., MPH, FACS, U.S. Surgeon General, participated in a subsequent media briefing in September 2003
to expand the scope of the campaign. NCPIE also licenses content from the campaign to support two statewide collaborative programs, Be MedWise Tennessee, and Be MedWise Arkansas. Lead State organizations are the Universities of Tennessee and Arkansas Cooperative Extension Services, the University of TN College of Pharmacy and the Univ. of Arkansas College of Pharmacy.
Convene Expert Project Advisory Team
Formulation of an external Project Advisory Team (PAT) to assist in the development, promotion, and dissemination of a turn-key educational workshop kit,
Maximizing Your Role as a Teen Influencer: What You Can Do To Help
Prevent Teen Prescription Drug Abuse.. The PAT for this project, which
will launch in October 2009 in conjunction with NCPIEs annual Talk About
Prescriptions Month campaign includes representatives from 14 organizations.
NCPIE also convened an external Project Advisory Team for the development,
promotion, and 2007 launch of its ongoing online NCPIE program, Medication Use Safety Training for SeniorsTM (MUST for SeniorsTM).
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Participate in External Coalitions
NCPIE currently participates in the following external coalitions or special
projects:
National Coordinating Council for Medication Reporting and Prevention
(NCC MERP)
National Consumers League/Agency for Health Care Research and Quality
National Medication Adherence Public Awareness Campaign
Safe Medication Disposal for ME (Maine) ProgramMember of project advisory team
Follow Directions: How to Use Methadone Safely Campaign Partner
New England Health Care Institute (NEHI) medication adherence improvement project
Maryland State Board of Pharmacy Acetaminophen Safety Campaign
American Pharmacists Association Safe Use of Acetaminophen Products Coalition
Use the Internet and (Pending) Use of Social Media
NCPIE currently maintains or promotes four educational Web sites:
www.talkaboutrx.orgprimary site; home for Talk About Prescriptions
Month;
www.bemedwise.orgsafe use of over-the-counter (OTC) medicines;
www.mustforseniors.orgtargeting older adults and caregivers;
www.learnaboutrxsafety.orgtargeting families, including older adults,
caregivers, parents and children; developed collaboratively for The Center for
Improving Medication Management (SureScripts) who own/maintain the site.
Upcoming campaign (online Tool Kit to address medicine abuse on college campuses) will include outreach via social media, including Facebook and Twitter).
I would once again like to thank you for inviting me to testify before this Subcommittee. I appreciate the work of this Subcommittee on Oversight and Investigations of the House Committee on Veterans Affairs. On behalf of all NCPIE member
organizations I thank you for your trust in our ability to assist you with this important work. I look forward to answering any questions you might have.
f
Prepared Statement of Solomon Iyasu, M.D., MPH, Director,
Division of Epidemiology, Office of Surveillance and Epidemiology,
Center for Drug Evaluation and Research, Food and Drug Administration,
U.S. Department of Health and Human Services
INTRODUCTION
Mr. Chairman and Members of the Committee, I am Dr. Solomon Iyasu, Director,
Division of Epidemiology, within the Office of Surveillance and Epidemiology in the
Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA or the Agency), which is part of the Department of Health and Human
Services (HHS). I am pleased to be here today to discuss FDAs role in identifying
and communicating drug safety issues, as well as our collaboration with the Department of Veterans Affairs (VA). We will first discuss the importance of FDA drug
regulation, including how the Agency manages drug safety issues and informs the
public when drug safety concerns arise. We will also discuss some specific examples
of how FDA and the VA have collaborated in furthering our mission to protect the
public health and keep our drug supply safe.
FDA DRUG REGULATION
FDA promotes public health through the regulation of prescription and over-thecounter drugs, which are an increasingly critical component in improving the health
of many Americans. FDA is charged by Congress with the authority to review new
drug applications for safety and effectiveness. FDAs drug review process is recognized worldwide as the gold standard, and we actively monitor the scientific bases
for our processes to ensure that they reflect advances in medical science.
Approval of a drug product is based on FDAs acceptance and review of data collected during the course of the drugs development, including the results of clinical
trials, demonstrating that the drug is safe and effective for its intended use. At least
half of the effort by FDAs premarket reviewers is dedicated to the assessment of
safety. Major changes have taken place in how drugs are evaluated, including a
complete evaluation of their metabolism, their interactions with other drugs, and po-
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diseases or conditions for which the drug provides a benefit, the availability of alternative therapies, and the consequences of not treating the disease. As more becomes
known about the potential risks or benefits of a drug, often its FDA-approved labeling will be revised so that it better reflects information on appropriate use. If labeling alone is inadequate to manage risks, additional actions may include revising
drug names or packaging, issuing Dear Health Care Professional letters (sometimes referred to as Dear Doctor letters), disseminating educational/special risk
communications, requiring restricted distribution programs, or withdrawing a drugs
approval.
HOW FDA COMMUNICATES ABOUT DRUG SAFETY ISSUES
FDA uses a broad range of methods to communicate drug safety information to
the public. Certain forms of communication are targeted to specific audiences (e.g.,
healthcare professionals or patients). Others are directed at more than one group
to ensure widespread dissemination of information about important drug safety
issues, including emerging drug safety issues. FDA continuously evaluates its communication efforts and modifies them to enhance their accessibility and effectiveness. We welcome public comment at any time, suggesting ways to improve our safety communications. The different types of drug safety communications are described
in more detail below.
Labeling. FDA-approved drug product labeling is the primary source of information about a drugs safety and effectiveness, and it summarizes the essential scientific information needed for the safe and effective use of the drug. Labeling for
prescription drug products is directed to healthcare professionals but may include
patient counseling information as well. For some prescription drugs, such as oral
contraceptives and estrogens, FDA determined several years ago that the safe and
effective use of these drugs required that additional labeling in nontechnical language be distributed directly to patients by their healthcare professional or pharmacist (Title 21 of the Code of Federal Regulations (CFR) 310.501 and 310.515). In
addition, FDA may require Medication Guides, a type of patient-directed labeling,
for products it determines pose a serious and significant public health concern (21
CFR 208) as part of a risk evaluation and mitigation strategy (REMS). FDA-approved patient labeling also may be provided by manufacturers for other drugs.
Early Communications about Ongoing Safety Reviews. Since August 2007, FDA
has issued Early Communications about Ongoing Safety Reviews to keep healthcare
professionals and the general public informed of postmarket safety issues that are
currently being evaluated by FDA. Early Communications are issued at the beginning of FDAs assessment, prior to conclusive determination of the clinical or public
health significance of the information under evaluation, and before a decision has
been made about what regulatory actions, if any, should be taken. They reflect
FDAs current analysis of available data concerning these drugs; posting the information as an Early Communication does not mean that FDA has concluded there
is a causal relationship between the drug and the emerging safety issue. It also does
not mean that FDA is advising healthcare professionals to discontinue prescribing
these products. In general, Early Communications have included a time frame for
when FDA anticipates completing the safety review and providing followup.
Public Health Advisories (PHAs). FDA issues PHAs to provide information regarding important public health issues to the general public, including patients and
healthcare professionals. For example, PHAs may highlight important safety information, inform the public about the completion of FDAs evaluation of an emerging
drug safety issue, announce the implementation of methods to manage the risks
identified for a marketed drug, or provide other important public health information.
PHAs regularly include recommendations to mitigate a potential risk and often
are issued in conjunction with other drug safety communications, such as Health
Care Professional Sheets. PHAs related to drugs are available through CDERs Web
site and disseminated via the MedWatch Partners Program.
Health Care Professional Sheets. FDA issues Health Care Professional Sheets,
which provide a summary of important and often emerging drug safety information
for a particular drug or drug class. Health Care Professional Sheets begin with a
summary Alert paragraph, followed by more detailed sections explaining the Alert,
including clinical considerations or recommendations for the healthcare professional,
information that patients should be made aware of and discuss with their
healthcare professional, a summary of the data that were the basis for the recommendations, and, when applicable, implications of the Alert. Health Care Professional Sheets are intended to provide adequate factual information to address potential questions from patients and facilitate a healthcare professionals consideration
of the drug safety issue.
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workflow system that allows for the integration of adverse event data reporting for
review and discussion at a later date. This information is then shared with CDRH
at regular intervals. The VA and CDRH are developing ways to share information
in a similar fashion for endoscopes.
Food and Drug Administration Amendments Act of 2007 (FDAAA)
As you know, in September 2007, Congress passed FDAAA, which included new
resources for medical product safety and new regulatory tools and authorities to ensure the safe and appropriate use of drugs. For example, under FDAAA, FDA can
require drug sponsors to make certain safety-related labeling changes and conduct
postmarketing studies and clinical trials instead of relying on voluntary actions. In
addition, if FDA determines that a REMSrisk evaluation and mitigation strategyis necessary to ensure that the benefits of a drug outweigh the risks of the
drug, FDA can require manufacturers to submit a REMS when a drug comes on the
market, or later if FDA becomes aware of new safety information.
Sentinel Initiative
FDAAA requires the HHS Secretary to develop methods to obtain access to disparate data sources and to establish a postmarket risk identification and analysis
system to link and analyze healthcare data from multiple sources. The Sentinel Initiative is FDAs response to this mandate. Its goal is to build and implement a new
active surveillance system that will eventually use electronic health information to
monitor the safety of all FDA-regulated products. On May 22, 2008, FDA launched
the Sentinel Initiative with the ultimate goal of creating and implanting the Sentinel Systema national, integrated, electronic system for monitoring medical product safety. The Sentinel Initiative is a long-term effort that must proceed in stages,
and this effort is well under way. FDA is collaborating with the Federal and private
sector in various activities that will inform the development of this system.
In December 2008, FDA held a public meeting on the Sentinel Initiative to obtain
input from stakeholders about the structure, function, and scope of the project. The
Director for the Center of Medication Safety at the VA was among the participants
at this day-long meeting, presenting on the issue of risk communication.
As an initial step to creating the Sentinel System, FDA is initiating various pilot
efforts to further the science of medical product surveillance. One of these pilots,
known as Mini-Sentinel II, will include our Federal partners. We look forward to
the VAs participation in this effort. The effort involves creating a distributed system that will focus on developing methodologies to obtain more information on
emerging drug safety issues. Mini-Sentinel II is a small-scale effort to conduct the
types of safety evaluations that FDA envisions doing on a larger scale with the Sentinel System. Medical product-adverse event pairs will be selected based on identification of priority safety issues from FDAs medical product Centers. Then a protocol for a query will be developed and agreed to by participating Federal partners.
Subsequently, each participating Federal partner will perform the analysis in their
database. The query will be translated into analytical code by the partner specifically developed and suited for the partners database structure. Summary results of
each Federal partners analysis will be submitted to FDA for further consideration.
Lessons learned from this pilot will inform the development of the Sentinel System.
The Sentinel System will augment the Agencys current postmarketing surveillance tools and strengthen FDAs ability to ensure that safe and effective new drugs
are available to the public and that the risks of marketed drugs are well understood.
CONCLUSION
FDA has a critical role in the detection and management of safety issues that are
identified after a drug is approved, including a critical role in communicating information to the public. Our goal, regardless of the communication tool employed, is
to make the most up-to-date drug safety information available to the public in a
timely manner so that healthcare professionals and patients can consider the information when making decisions about medical treatment and be aware of uncertainties in the data. Our ability to fulfill our mission is enhanced by our partnerships
with patients, physicians, pharmacists, industry, State regulators, and other Federal
partners like the VA. Together we can help ensure the safe use of marketed drugs
by providing the best possible information to the American public.
Once again, thank you for the opportunity to testify before the Committee today.
We are happy to respond to questions.
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Prepared Statement of Belinda J. Finn, Assistant Inspector General
for Audits and Evaluations, Office of Inspector General,
U.S. Department of Veterans Affairs
INTRODUCTION
Mr. Chairman and Members of the Subcommittee, thank you for the opportunity
to discuss systemic weaknesses impacting the Veterans Health Administrations
(VHA) ability to accurately account for its inventories of non-controlled drugs in
VHA medical facilities and consolidated mail outpatient pharmacies (CMOPs). We
issued two recent Office of Inspector General (OIG) reports, Audit of VA Consolidated Mail Outpatient Pharmacy Inventory Accountability and Audit of Veterans
Health Administrations Management of Non-Controlled Drugs, related to this issue.
I am accompanied by Irene Barnett, Ph.D., Audit Manager, Bedford Office for Audits and Evaluations, OIG.
BACKGROUND
VHA medical facilities and CMOPs dispensed about 126 million prescriptions for
VA patients and spent $3.7 billion on pharmaceuticals in fiscal year (FY) 2008. Prescription drugs are generally categorized as controlled or non-controlled. Non-controlled drugs are not regulated under the Controlled Substances Act 1970 due to the
reduced risk for abuse and addiction. Approximately 95 percent of the pharmaceutical spending was on non-controlled drugs. Also, non-controlled drugs are not
subject to the same stringent inventory and oversight controls that controlled drugs
are subject to, yet some non-controlled drugs are expensive, others contain active
ingredients that can be used to manufacture illicit drugs, and some are considered
to be at high risk of diversion given the high street value of the specific drug. Within VHA, prescription medications are generally dispensed directly to veterans by facility inpatient or outpatient pharmacies or by mail from a medical facilitys pharmacy or a CMOP. The CMOPs spend about twice as much money on pharmaceuticals than VHA medical facilities. As part of our recent oversight of pharmaceutical inventories, we visited two of VHAs seven CMOP operations in Charleston,
SC, and Dallas, TX, and six of VHAs medical facilities in Fayetteville, NC, New
York, NY, Long Beach, CA, Wichita, KS, Seattle, WA, and Spokane, WA. In addition, we also analyzed the inventory records of over 30 VA medical centers.
We reported VHA medical facilities and CMOPs could not accurately account for
non-controlled drug inventories because of inadequate inventory management practices, recordkeeping, and inaccurate pharmacy data. VHA needs to improve its ability to account for non-controlled drugs to reduce the risk of diversion and standardize its pharmacy inventory practices among its medical facilities and CMOPs.
Without improved controls, VHA cannot ensure its non-controlled drug inventories
are appropriately safeguarded, nor can VHA accurately account for these expensive
inventories.
FINDINGS
VHA cannot accurately account for its non-controlled drug inventories because it
has neither implemented nor enforced sufficient controls to ensure pharmacy inventory practices are standardized and pharmacy data is accurate. Furthermore, VHA
does not currently require its facilities to monitor any non-controlled drugs on an
ongoing basis.
We found that both CMOPs and VHA medical facilities maintain inventory management controls and use systems of inventory control that rely upon annual physical counts of drugs. However, we identified significant weaknesses in how well the
facilities perform physical counts and adjust inventory records.
Inadequate Inventory Controls Led to Significant Inventory Variances
VHA Handbook 1761.2, VHA Inventory Management, requires that an annual
wall-to-wall physical inventory be performed for all items. In addition, VHAs Pharmacy Inventory Guidelines state that inventory quantities of an open product should
be estimated to the nearest tenth of a bottle. The CMOPs did not perform complete
annual physical counts for all items, as required and inconsistently estimated their
inventory quantities of open products. Additionally, the inventory management system used by most CMOPs does not always track drug dispensing. CMOP personnel
physically count all drugs that are manually dispensed, but they do not count all
drugs dispensed from individual pill dispensers because they considered the physical
count of open products to be too labor intensive.
We performed inventory analyses at two of VAs seven CMOPs supporting operations nationwide and identified pill variances ranging from a negative variance of
3,092 pills to a positive variance 192,498 pills. The existence of these variances demonstrated the unreliability and inaccuracy of the CMOPs inventory records. Fur-
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drug through the ordering system without being identified as a specific user. The
same employee could then use their unique ID and password to reduce the inventory balance and divert the drug.
Drug Transactions Not Accurately and Consistently Recorded
VHA has established some procedures regarding the use of VistA to record drug
transactions; however, controls are not in place to ensure that accurate and complete information on drug transactions is captured. For example, we found that local
pharmacy personnel are not consistently recording information in VistA on transactions such as pharmacy stock transfers and drug returns. Prescription labels can
be reprinted when an original label is damaged although the reprint function in
VistA should not generally be used to dispense drugs. Some dispensing data may
be incomplete because pharmacy personnel are inappropriately using the label reprint function in VistA to dispense drugs. These practices negatively impacted the
reliability of inventory information.
Pharmacy personnel from six medical facilities we visited are using the reprint
function to dispense drugs to patients, which can affect the accuracy of drug dispensing captured in VistA. The VistA application lacks adequate controls to track
why a reprint label is being generated or to ensure that the function is being appropriately used. Further, VistA captures the quantity of drugs dispensed using the reprint function only if the original prescription was not released to the patient. Without procedures to standardize the use of the reprint function and to capture data
on drug transfers, accountability of drug inventories is compromised.
VHA facilities are not consistently capturing information on the quantities of
drugs originally dispensed and then returned to inventory for reuse. Pharmacy managers at VHA facilities told us some personnel are returning drugs to inventory
without adjusting inventory records in VistA, which inflates a facilitys dispensing
data. We calculated a positive inventory discrepancy for at least one drug at 24 of
31 VHA medical facilities where we specifically analyzed inventory information. We
estimated that these facilities had an excess of about 87,000 pillsor 10 percent
available to dispense. These pills are available to dispense or divert since they do
not exist according to the inventory records.
The VHA Directive 98020, Drug Accountability Software, which required facilities to monitor at least 20 non-controlled drugs for possible diversion, expired in
2003. At the time of our audits, VHA had not provided facilities with technical guidance on how to monitor non-controlled drugs on an ongoing basis to detect diversion,
or taken steps to improve the usefulness of its annual physical inventory information.
Most pharmacy managers in VHA medical facilities reported that they monitor at
least one non-controlled drug for diversion on an ongoing basis, with most monitoring one to five drugs. Typical action includes comparing data on drug purchasing
and dispensing to identify unaccounted for drugs. The willingness to monitor certain
non-controlled drugs in the absence of VHA policy is a positive action. However,
over one-third of pharmacy managers reported that they lack adequate information
to monitor non-controlled drugs for diversion. Given the number of high-risk noncontrolled drugs medical facilities maintain in stock, VHA needs to identify certain
high-risk drugs that should be monitored and provide facilities with guidance on
how to monitor and safeguard these drugs on an ongoing basis.
Overall, both VHAs VistA and CMOP inventory management software require
improvements to allow medical facilities and CMOPs to better account for pharmacy
inventory. In 2003, VHA initiated the Pharmacy Re-engineering project to make improvements to VistA. The project was slated for completion in 2005, but this project
has experienced significant delays. Current schedule projections are that the project
may not be completed until 2014. Since needed upgrades may take years to be fully
implemented, it is vital that VHA take more immediate action to improve accountability over non-controlled drug inventories.
CONCLUSION
With pharmaceutical expenditures exceeding $3.7 billion in FY 2008 and future
costs expected to increase, VHA needs accurate inventories and strong recordkeeping to account for non-controlled drug inventories. OIG audits reported large
variances in the amount of non-controlled drugs at VHA medical facilities and
CMOPs and concluded that VHA does not have reliable inventory information that
could detect the loss or unauthorized diversion of drugs. The implementation and
enforcement of inventory controls to provide accurate and complete information is
imperative to VHAs ability to account for, manage, and safeguard non-controlled
drugs.
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We recommended the Under Secretary for Health take actions to improve accountability over non-controlled drugs, including:
Enforcing requirements for conducting annual wall-to wall inventories.
Ensuring annual physical inventory reports are reasonably accurate and pharmacy managers are held accountable for the accuracy of annual inventories.
Developing policy and establishing controls to monitor and control adjustments
to drug inventory records.
Enforcing compliance with the policy for returned drugs.
Establishing procedures that restrict a single user from ordering, receiving, and
adjusting against the same drug and removing generic user IDs and passwords.
Developing procedures to identify high-risk non-controlled drugs and requiring
pharmacy managers to monitor those drugs.
Developing appropriate internal controls to ensure information on drug dispensing, drug transfers, and drug returns is accurately and consistently recorded in VistA.
Limiting access to the VistA label reprint function to appropriate pharmacy personnel.
The Under Secretary for Health agreed with our findings and recommendations
to improve accountability over non-controlled drug inventories. VHA provided acceptable implementation plans to address the recommendations. We will followup on
the implementation of actions to address the report recommendations.
Mr. Chairman, thank you for the opportunity to discuss these important issues.
We would be pleased to answer any questions that you or other Members of the
Subcommittee may have.
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Prepared Statement of Michael A. Valentino, R.Ph., MHSA,
Chief Consultant, Pharmacy Benefits Management Services, Veterans
Health Administration, U.S. Department of Veterans Affairs
Mr. Chairman, Ranking Member, and Members of the Committee: thank you for
providing me this opportunity to discuss the Department of Veterans Affairs (VA)
Pharmacy Benefits Management Services (PBM) program, including our national
Formulary and patient safety initiatives. I am accompanied today by Dr. Chester
B. Good, Chair of the VA Medical Advisory Panel and Dr. Paul Tibbits, Deputy
Chief Information Officer for Enterprise Development.
Drug therapy is an essential component to quality preventative, curative, and
post-operative healthcare. Each Veteran enrolled in the VA healthcare system is eligible to receive prescription medications, over-the-counter medications, and medical
and surgical supplies under VAs comprehensive medical benefits package. Generally, these pharmaceuticals must be prescribed by a VA provider and are made
available via the VA National Formulary process. In 2008, VA provided approximately 126 million outpatient prescriptions to more than 4.4 million patients. Our
error rate for these prescriptions is very low; less than 1 in every 294,000. I can
confidently say that VA is meeting the pharmaceutical needs of Veterans and that
we are striving every day to provide even better care to more of Americas heroes.
My testimony will describe how VA manages pharmacy benefits, the offices and procedures we have in place to ensure Veterans receive safe and quality care, and discuss VAs National Formulary. Before concluding, my statement will also provide information on VAs recently initiated Medication Reconciliation program.
Pharmacy Benefits Management
VAs Pharmacy Benefits Management (PBM) program works to enhance the clinical outcomes and improve the health of Veterans through the appropriate use of
pharmaceuticals. PBM provides leadership and governance for pharmaceutical activities and professional pharmacy practice in the Veterans Health Administration
(VHA) and provides advice and support regarding pharmaceutical issues to Veterans, the Under Secretary for Health, field directors, and pharmacy staff across the
system. The PBM organization consists of six primary specialty areas: the Clinical
Informatics section; the Consolidated Mail Outpatient Pharmacy (CMOP) program;
Adverse Drug Event Reporting (VA ADERS); Emergency Pharmacy Services (EPS);
VA National Formulary (VANF) management; and the VA Center for Medication
Safety (VA MedSAFE).
Clinical Informatics
The PBM Clinical Informatics section provides operational oversight to the information systems used by PBM and all pharmacy operations nationwide. This section
plans and establishes the mechanisms by which VA meets general program goals
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Computerized Patient Record System (CPRS), electronic medication order entry,
automated prescription fulfillment, and the Bar Code Medication Administration
(BCMA) system. The electronic health record (EHR) currently provides automated
checks for allergies and possible drug interactions, further improving patient safety
and care. VAs Center for Medication Safety (VA MedSAFE) is a national, comprehensive pharmaco-vigilance program that emphasizes the safe and appropriate
use of medications. VA MedSAFE utilizes different methods and tools, including
passive and active surveillance, to continuously monitor for potential ADEs, including the use of VA ADERS as previously described.
An ADE is defined as an unintended effect of a drug that occurs secondary to drug
administration. In many instances, VA MedSAFE directly and promptly notifies providers across VAs healthcare system if patients are at risk through its Risk Reduction efforts. VA, DoD and FDA have a MOU that allows close collaboration on specific post-marketing surveillance efforts and other drug and vaccine safety projects.
These efforts are conducted through FDAs newly established Sentinel Initiative and
its Office of Surveillance and Epidemiologys Center for Drug Safety and Epidemiology Research. Medications and prescriptions are essential to effective healthcare
management, but inaccuracies can have severe repercussions.
Evaluating preventable ADEs, providing interventions to decrease preventable
ADEs, and educating the field on best practices reduce the likelihood of ADEs occurring. By conducting and promoting medication safety projects at the regional and
national levels, VA provides safe and effective pharmaceutical care to Veterans.
Through the national roll-up system and data analysis provided by VA MedSAFE,
each facility and VISN can benchmark themselves against national trends. We are
unaware of any other healthcare system with as robust and well-developed a system
for tracking, assessing and acting on drug-related safety issues within their patient
population.
VA provides consumer medication information sheets on each new and renewed
prescription. VA is highly engaged with patient education on medications, with local
medical centers developing policy for teams of clinicians to provide medication education, involving physicians, nurse practitioners, physician assistants, clinical pharmacy specialists, pharmacists, nurses, and other allied healthcare providers. Clinical
Pharmacy Specialists and clinical pharmacists are key members of the healthcare
team and can assist in optimizing drug therapy and improving medication safety for
outpatients.
Medication Reconciliation, a Joint Commission National Patient Safety Goal, is a
process which mitigates the risk of ADEs that occur at transitions of care. It does
this by addressing discrepancies between a patients accounting of his or her medication use and the medication lists in the medical record every time a medication
is dispensed, changed, or added to the medication regiment. There are many barriers to implementation including interoperability, software development, staff and
organization adoption, and a changing Joint Commission National Patient Safety
Goal.
The VA Medication Reconciliation Initiative, launched in December 2008, is
tasked with facilitating safe, high quality, effective, and above all, Veteran-centered
medication reconciliation throughout the VA system. This multidisciplinary effort
includes a VA Medication Reconciliation Toolkit, Educational Video, Facility Monitor, External Peer Review Process, and patient informational Web site called Medications: Play it Safe! on the My HealtheVet Web site. This initiatives workgroups
continue to improve patient and staff resources and tools to improve documentation
and monitoring of this process. In the coming months, we will continue to bring together VA innovators with those in DoD and the private sector to establish a worldclass medication reconciliation program for Veterans and to provide guidance for
this challenging endeavor.
Conclusion
Mr. Chairman, VA has developed a remarkable pharmacy benefits management
system that provides Veterans safe and effective medication to improve their
healthcare. Our National Formulary is based on the best clinical research and
leverages the size of our patient population and Department to procure medications
at a low cost. Thank you again for the opportunity to testify. My colleagues and I
are prepared to answer your questions.
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Statement of American Federation of Government Employees, AFLCIO
The American Federation of Government Employees (AFGE) appreciates the opportunity to present its views on veterans pharmaceutical needs. AFGE represents
approximately 180,000 employees in the Department of Veterans Affairs (VA), more
than two-thirds of whom are Veterans Health Administration (VHA) professionals
on the frontlines treating the physical and mental health needs of our veteran population.
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Understaffing can also have wider ramifications. For example, the Minneapolis
VAMC has one of the busiest VA chemotherapy departments in the country. The
facility recently built a chemotherapy satellite pharmacy that complies with new
OSHA/NIOSH negative pressure regulations for preparing chemotherapy that
were intended to reduce the risk of harmful exposure of IV room staff to hazardous
substances. Even though the satellite was completed over a year ago, management
has not filled the pharmacy departments request for an additional technician who
is needed to work in the satellite, citing budget constraints. As a result, the facility
has still not moved chemotherapy preparation to this satellite, and staff continues
to prepare chemotherapy in a positive pressure room in violation of the new regulations.
Short staffing also limits the ability of the pharmacy workforce to comply with
the large number of VA directives that are issued on a regular basis to improve patient care.
Another AFGE member reported that at her facility, the pharmacy does not have
a triage pharmacist on staff that could extend maintenance medications until the
next primary care appointment if the patient runs short.
AFGE members also expressed concern about the large number of pharmacists
who only have clinical duties. In contrast, pharmacy production and verification
functions, which involve extensive requirements for providing medications to patients, remain short staffed.
Other Comments
CMOPs
AFGE urges this Subcommittee to encourage the replication of best practices of
ergonomic interventions in place at some Consolidated Mail Outpatient Pharmacies
(CMOPs) to other CMOPs and hospital outpatient verification high production
areas.
Formularies
AFGE pharmacist members expressed concern about the unintended impact of
performance measures related to cost savings. In order to meet Performance Measures, facilities often switch medications from a drug in one class to another drug
in the same class or a similar class. Frequent switching frustrates and confuses our
veterans. It is also perplexing to staff why VHA allows so many deviations to the
formulary by pharmacy benefit managers at the VISN level.
Members also pointed out problems that result from other hospital units using
different products than the pharmacy. For example, the pharmacy formulary allows
the use of one type of nutritional supplement for veterans who are outpatient, while
the dietetic service has a separate contracting process and therefore uses another
product for inpatient care. As a result, when a veteran changes from inpatient to
outpatient status, there are continuity of care problems. Similarly, many of the
wound care/dressing supplies provided by Supplies, Processing and Delivery (SPD)
on an inpatient basis are different than those supplied by the pharmacy for outpatients. This also leads to confusion and coordination problems for clinicians and
patients.
Information Technology
Members indicated a need for a number of IT upgrades; for example, it would be
helpful to upgrade the VA intravenous (IV) package/IV labeling, and also to have
IV pumps that could download infusion data into the computerized patient record
system.
Patient Safety
AFGE urges increased oversight of the medication reconciliation process. The Center for Patient Safety should look closely at VHAs difficulties in complying with
Joint Commission (JCAHO) performance criteria in this area, and the adverse impact of noncompliance on other inpatient staff members.
A pharmacist on another facility expressed concern about the practice of allowing
contract nurses from the state nursing homes, rather than the veterans treating
physician, to make requests for medication refills without any accountability.
AFGE thanks the Subcommittee for the opportunity to provide input into this
issue.
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Statement of Hon. Cliff Stearns,
a Representative in Congress from the State of Florida
Thank you Mr. Chairman. I appreciate your holding this hearing to examine the
management of the Department of Veterans Affairs (VA) pharmacy program.
The development of prescription medications that relieve suffering, prevent, cure,
and help manage illnesses has revolutionized modern medicine and is improving the
quality of life for many of our ill, injured and elderly veterans.
Last year, VA filled over 125 million prescriptions for veteran patients and expects that amount to double in 2010 to more than 254 million prescriptions.
In 1997, with the increased use of pharmaceuticals and concerns over rising drug
costs and geographic variability, VA was prompted to establish a single National
Formulary to help manage costs and improve consistency across the VA healthcare
system. The National Formulary provides VA with leverage to purchase in bulk and
increase the cost-effectiveness of VAs pharmacy program.
A formulary system has the potential to also help educate physicians and patients
about drugs, ensure the use of quality drug products and promote evidence-based
management of disease.
However, it can also generate serious concerns about quality of care because
formularies restrict the different classes of drugs available. For instance, a drug on
the list may not be effective for 100 percent of the patients or it could be unexpectedly discontinued. Additionally there is a lengthy process for the inclusion of a new
or breakthrough drug, and there are questions about the fairness and responsiveness for the approval of the use of a non-formulary drug to meet the specific needs
of a veteran patient.
VAs proper management of the formulary system is vital to ensuring our veterans receive the highest quality of care and access to the most up-to-date medications they deserve.
Todays hearing will explore these important issues, and I would like to thank all
of our witnesses today for their testimony and I look forward to the hearing.
Thank you Mr. Chairman. I yield back the balance of my time.
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MATERIAL SUBMITTED FOR THE RECORD
U.S. Department of Health and Human Services
Food and Drug Administration
Rockville MD.
November 6, 2009
Hon. Michael H. Michaud
Chairman
Subcommittee on Health
Committee on Veterans Affairs
House of Representatives
Washington, D.C. 20515
Dear Mr. Chairman:
This letter is in follow-up to the September 22, 2009, hearing entitled Is the U.S.
Department of Veterans Affairs (VA) Meeting the Pharmaceutical Needs of Veterans? An Examination of the VA National Formulary Issues of Patient Safety, and
Management of the Pharmacy Benefits Program. During that hearing you asked
how the Food and Drug Administration (FDA or the Agency) deals with complaints
about conflict of interest. After receiving further clarification from your staff, below
is our response your question, as it specifically pertains to potential conflicts of interest and FDA advisory committee panels.
FDAs advisory committees provide independent expert advice to the Agency on
scientific, technical, and policy matter related to the development and evaluation of
FDA-regulated products. Advisory committees enhance FDAs ability to protect and
promote public health by ensuring it has access to advice, in a public manner, as
permitted by existing laws and regulations. Although advisory committees provide
recommendations to FDA, FDA makes the final decisions.
FDAs advisory committee program is governed by a number of Federal laws and
regulations that set forth standards for convening advisory committees and reviewing potential conflicts of interest, among other things. FDA also has developed guidance documents that describe the Agencys recommendations and policy related to
our advisory committees.
FDA is committed to strictly adhering to the laws and regulations governing the
process for selecting advisory committee members. In August 2008, FDA implemented several improved policies and procedures to strengthen its management of
advisory committees. These policies and procedures are detailed in the form of guidance documents and their goal is to make the process of seeking advice from independent experts as open, public and transparent as possible.
One guidance, Procedures for Determining Conflict of Interest and Eligibility for
Participation in FDA Advisory Committees, describes how FDA determines whether
an individual invited to participate in an FDA advisory committee has a potential
conflict of interest and whether he/she is eligible to participate in an advisory meeting. The approach set forth in this guidance makes the Agencys review of potential
conflicts of interest more stringent than current legal requirements and previous
FDA guidance. For example, according to the new guidance:
If an individual, their spouse, or minor child has potentially conflicting financial
interests totaling more than $50,000, they would not ordinarily be allowed to
participate in that meeting.
Four specific scenarios are outlined where the conflict is significant and FDA
does not intend to issue a waiver, even if the potential personal conflict is below
$50,000.
Before a waiver is issued, FDA will require a showing that the waiver is necessary to afford the committee essential expertise.
FDA will limit the number of waivers that are granted, as is now required by
law.
Another guidance, Public Availability of Advisory Committee Members Financial
Interest Information and Waivers, focuses on ensuring that when FDA grants a
waiver, the circumstances of that waiver are made clear and transparent to the public. Therefore, all waivers and advisors disclosures of potentially conflicting interests are posted to the FDA Web site. In most cases, FDA posts these documents at
least 15 days prior to the relevant advisory committee meeting. These changes help
to make the basis for FDAs decision to grant a waiver clearer to the public.
A fact sheet providing a detailed summary of each guidance is enclosed and can
also be found on FDAs Web site at http://www.fda.gov/ociadvisory/factsheet
080408.html. These guidances enable FDA to improve consistency in the handling
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of potential conflicts of interest and to provide greater clarity to the public. FDA
makes the laws, regulations, and guidance documents pertaining to advisory committees available through our Web site at www.fda.gov/advisorycommittees to provide ready access to the statutory aid regulatory framework that FDA advisory committees operate within, and to describe the steps that FDA has taken to enhance
decision-making, increase transparency, and strengthen public confidence in our advisory committee program.
Thank you for your interest in this matter. If you have further concerns, please
let us know.
Sincerely,
Jeanne Ireland
Assistant Commissioner for Legislation
Enclosure:
Fact Sheet: Improved Policies and Procedures Regarding Transparency, Public
Disclosure for FDA Advisory Committees
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disclosure will make them clearer and more consistent. These changes will make the
basis for FDAs decision to grant a waiver clearer to the public.
Final Guidance on Voting Procedures at Advisory Committee Meetings
This guidance is intended to ensure integrity of the voting process at advisory
committee meetings. It recommends that any question put to a vote be clearly and
collectively understood by those voting, and it urges that there be a robust discussion of the issues at the heart of the question before voting takes place. The guidance also recommends that votes be cast simultaneously rather than sequentially.
This is intended to avoid voting momentum, in which voters may be influenced,
even subconsciously, by the votes of those who precede them.
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The page offers an opportunity for consumers to provide feedback on the site
our advisory Committeesand well post summaries of that feedback.
http://www.fda.gov/oc/advisory/factsheet080408.html
f
Committee on Veterans Affairs
Subcommittee on Health
Washington, DC.
October 1, 2009
Honorable George J. Opfer
Inspector General
Office of Inspector General
U.S Department of Veterans Affairs
801 I Street, NW
Washington, DC 20001
Dear Inspector General Opfer:
Thank you for the testimony of Belinda J. Finn, Assistant Inspector General for
Audits and Investigations at the U.S. House of Representatives Committee on Veterans Affairs, Subcommittee on Health Oversight Hearing on Is the VA Meeting
the Pharmaceutical Needs of Veterans? An Examination of the VA National Formulary, Issues of Patient Safety, and Management of the Pharmacy Benefits Program. that took place on September 22, 2009.
Please provide answers to the following questions by November 12, 2009, to Jeff
Burdette, Legislative Assistant to the Subcommittee on Health.
1. Do you believe that the VA has derived sufficient benefit from the centralizing
of contracting responsibilities at the National CMOP office? In other words,
does the national CMOP remain the preferred model for acquiring pharmaceutical supplies and services?
2. In addition to the VA issuing and enforcing policies to improve accountability
of non-controlled drugs, what additional tools does the VA need for effective
enforcement of the new policies? For example, Ms. Finns testimony noted the
need to improve IT. Are there other tools that the VA needs to acquire?
Thank you again for taking the time to answer these questions. The Committee
looks forward to receiving your answers by November 12, 2009.
Sincerely,
MICHAEL H. MICHAUD
Chairman
This is in response to your October 1, 2009, letter following the September 22,
2009, hearing on Is the VA Meeting the Pharmaceutical Needs of Veterans? An Examination of the VA National Formulary, Issues of Patient Safety, and Management
of the Pharmacy Benefits Program. Enclosed is our response to the additional hearing questions. This information has also been provided to Congressman Henry E.
Brown, Jr., Ranking Republican Member, Subcommittee on Health.
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Thank you for your interest in the Department of Veterans Affairs.
Sincerely,
GEORGE J. OPFER
Inspector General
Enclosure
[An identical letter was sent to Hon. Henry E. Brown, Jr., Ranking Republican
Member, Subcommittee on Health, Committee on Veterans Affairs.]
Question 1: Do you believe that the VA has derived sufficient benefit from the
centralizing of contracting responsibilities at the National CMOP Office? In other
words, does the national CMOP remain the preferred model for acquiring pharmaceutical supplies and services?
Response: The VAs National Acquisition Center (NAC) is responsible for purchasing pharmaceuticals, supplies, and services dispensed by the national community mail outpatient pharmacies (CMOPs). Centralizing this function provides VA
the following benefits:
Opportunities to leverage buying power to obtain lower prices and volume discounts.
Decrease in the potential for conflict of interest situations by having independent contracting actions.
Creation of a professional acquisition staff dedicated to supporting pharmaceutical contract initiatives.
Improvement in the compliance with the Federal Acquisition Regulation and
VA Acquisition Regulation.
The CMOP is a preferred model for dispensing pharmaceutical supplies and services because automation allows for safety in the dispensing of pharmaceuticals and
it is less expensive due to better drug pricing and greater efficiencies realized by
relying on seven CMOPs as opposed to individual VA medical centers and clinics.
Question 2: In addition to the VA issuing and enforcing policies to improve accountability of non-controlled drugs, what additional tools does the VA need for effective enforcement of the new policies? For example, Ms. Finns testimony noted
the need to improve IT. Are there other tools that the VA needs to acquire?
Response: In our report, Audit of the Veterans Health Administrations Management of Non-Controlled Drugs (June 23, 2009), we identified several weaknesses in
the Veterans Health Information System and Technology Architecture (VistA)the
information system the Veterans Health Administration (VHA) uses to manage
pharmacy services at its medical facilities. The current VistA system cannot provide
information to accurately account for a facilitys on-hand drug inventory.
In 2003, VHA launched the Pharmacy Re-Engineering (PRE) project to make improvements to VistA. We did not evaluate the design of the project or results of system tests, but Pharmacy Benefits Management officials told us that this new system
is expected to address VistA deficiencies. The PRE project was halted as part of
VAs Office of Information and Technologys review of VA system development
projects, and has not yet fully restarted. Other IT systems or tools that would improve accountability over inventories include centralization of billing and drug file
management, and Radio Frequency Identification (RFID) labeling for pharmaceuticals.
During our recent audits, the Pharmacy Benefits Management Services indicated
that they would like to see the creation of specialty CMOPs. Currently, each CMOP
manages many low volume products. By centralizing the low volume products, a
specialty CMOP can bring the volume of those products up to a higher level and
eliminate the distribution of those products at other CMOPs; potentially enabling
CMOPs to manage inventory better. To recognize these improvements, CMOPs also
need more robust software for billing customers. A system is needed where the
CMOP that fills and bills for the prescription is transparent to the medical center.
For drug file management, there is currently little standardization of stock across
the system. Improvements could be realized by standardizing stock lists and prices.
Currently, CMOPs attempt to maintain prices on several thousand line items of inventory and predictably inventory information is not accurate at given points in
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time. Managing the CMOP stock list centrally would enable CMOPs to vastly improve their drug file management and allow them to follow the private industry
model where prices are pushed out to each CMOP from a central location.
The use of a RFID chip inside labels would enable CMOPs to electronically track
stock from the time it came into their facilities until the time it left. If CMOP suppliers and United States Postal Service used this same technology, CMOPs could
track drugs through the entire supply chain right up to the point where they reach
the patient. Currently, costs appear prohibitive, but RFID pricing technology seems
to be decreasing rapidly and VA should leverage future inventory management tools
that enable the tracking and accountability for drugs through the entire supply
chain.
f
Committee on Veterans Affairs
Subcommittee on Health
Washington, DC.
October 1, 2009
Honorable Eric K. Shinseki
Secretary
U.S. Department of Veterans Affairs
810 Vermont Avenue, NW
Washington, DC 20240
Dear Secretary Shinseki:
Thank you for the testimony of Michael Valentino, Chief Consultant to the Pharmacy Benefits Management Service at the U.S. House of Representatives Committee on Veterans Affairs, Subcommittee on Health Oversight Hearing on Is the
VA Meeting the Pharmaceutical Needs of Veterans? An Examination of the VA National Formulary, Issues of Patient Safety, and Management of the Pharmacy Benefits Program. that took place on September 22, 2009.
Please provide answers to the following questions by November 12, 2009, to Jeff
Burdette, Legislative Assistant to the Subcommittee on Health.
1. How are new drugs added to the VA national formulary? How are requests
from VISNs and local facilities to add new drugs to the formulary handled?
How often is the national formulary updated and when was the last update?
2. It is our understanding that each VA facility must institute a process to review requests for drugs that are not on the formulary. What are the respective roles of the VA medical center, VISN, and the VA central office in ensuring that the review process for non-formulary drug requests are not subjective
and based on objective criteria?
3. What percent of non-formulary drug requests are approved? If such requests
for non-formulary drugs are not approved, what are some typical reasons for
the non-approval? Does the VA track and store data on non-formulary drug
requests?
4. In 2000, a report by the Institute of Medicine found that the VAs national
formulary lacked essential systems to assure that new drugs are expeditiously reviewed. Please discuss the steps that the VA has taken to address
this deficiency.
5. How does the VA handle issues of patient safety and prevent adverse drug
interactions for veterans who fill their prescriptions through the VA and private pharmacies?
6. What is the VA doing to encourage medication compliance among veterans to
maximize the results of the drug therapy?
7. The VAs November 2002 directive on VA National Dual Care Policy expired
in July 2007. Have there been any updates to the directive? If not, are there
plans to issue an updated directive?
8. Since the VA developed an integrated Web-based application that fully
automates the VAs adverse drug event reporting process, has the reporting
increased? If so, by how much? What does the VA do with this data? Who reviews the reports and what action, if any, is taken? For example, are there
a certain number of adverse drug events that are reported before the VA releases guidance?
9. Please describe the work and role of the VA Center for Medication Safety. For
example, what are some examples of the medication safety projects that this
Center implements? How does the Center educate the field on safe and best
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practices to minimize adverse drug events? What are some examples of the
research that the Center has translated into national policy?
10. Please describe the VAs interactions with FDA on drug recalls. Does the VA
follow the FDAs lead? Or, does the VA have the authority to halt the use of
the prescription drugs by the veterans before FDA officially initiates the recall?
11. As you know, off-labeling is use of drugs outside of the approved indications
by FDA. How prevalent are off-label prescriptions at the VA? And how does
the VA deal with off-label drug use in cases where there is little or not supportive evidence of benefit or safety in a population or for a medical condition?
12. It is our understanding that some VA facility directors confer prescribing authority to certain nurses, pharmacists, and physician assistants if the state
provides this authority and if it is cosigned by a medical doctor. What guidance and oversight is provided by the central VA office?
13. Based on the findings of the Inspector Generals June 2009 audit reports,
what steps has the VA taken to address issues identified with the management of non-controlled drugs and the CMOP contract?
14. Why did the VA allow the directive on Drug Accountability Software to lapse
in 2003? Are there plans for an updated directive?
Thank you again for taking the time to answer these questions. The Committee
looks forward to receiving your answers by November 12, 2009.
Sincerely,
MICHAEL H. MICHAUD
Chairman
Question 1: How are new drugs added to the VA national formulary? How are
requests from VISNs and local facilities to add new drugs to the formulary handled?
How often is the national formulary updated and when was the last update?
Response: The Department of Veterans Affairs (VA) policy (http://vaww1.va.gov/
vhapublications/ViewPublication.asp?publID=1834) requires that drugs newly approved by the Food and Drug Administration (FDA) be automatically reviewed for
VA National Formulary (VANF) as soon as sufficient safety and efficacy information
becomes available. In addition, requests for changes in a VANF drug status may be
submitted to the pharmacy benefits manager (PBM) by a Veterans Integrated Service Network (VISN) formulary committee, the VISN pharmacist executive committee
(VPE), the Medical Advisory Panel (MAP), a Veterans Health Administration (VHA)
Chief Medical Consultant, or a VHA Chief Medical Officer. An individual or group
of physicians may submit a request for VANF addition through its VISN Formulary
Committee(s). Decisions for VANF listing are evidence-based and made by consensus of the MAP and VPE Committees. The VANF is updated monthly, provided
that there are changes to be posted. The last two formulary updates occurred on
July 1, 2009, and October 7, 2009.
Question 2: It is our understanding that each VA facility must institute a process
to review requests for drugs that are not on the formulary. What are the respective
roles of the VA medical center, VISN, and the VA central office in ensuring that
the review process for non-formulary drug requests are not subjective and based on
objective criteria?
Response: VA policy requires that a non-formulary request process exist at each
VA medical center (http://vaww1.va.gov/vhapublications/ViewPublication.asp?publ
ID=1834).
This policy is intended to assure that decisions are evidence-based and timely.
Routine requests for non-formulary agents are reviewed and the requestor is notified of the decision within 96 hours of receipt of a completed non-formulary request.
Emergency requests for non-formulary agents are immediately addressed by individual(s) identified in local VA medical center policy. If the degree of urgency or
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emergency is in question, the drug is provided immediately and the nature of the
urgency or emergency is reviewed afterward.
Non-formulary drugs that have received FDA approval are only to be approved
when:
1. A documented contraindication exists to the formulary agent(s)
2. A documented adverse reaction occurred to the formulary agent(s)
3. A documented therapeutic failure to formulary therapeutic alternatives exists
4. No formulary alternative exists
5. The patient has previously responded to a non-formulary agent and serious
risk is associated with a change to a formulary agent; or
6. Other circumstances having compelling evidence-based clinical reasons
All physician-initiated appeals of a non-formulary drug request are received and
adjudicated by the facility chief of staff.
Medical center management, VISN pharmacist executives (VPE) and VA Central
Office Pharmacy Benefits Management (PBM) Service staff have the responsibility
to assure the intent of the VA policy is followed. Quarterly reports from VPEs are
sent to the PBM Service. These reports show the number of non-formulary requests
received, approved and denied, and the average processing time. Evidence-based
prescribing guidance documents, when applicable, are the objective criteria used to
assist clinicians in the non-formulary review process.
Question 3: What percent of non-formulary drug requests are approved? If such
requests for non-formulary drugs are not approved, what are some typical reasons
for the non-approval? Does the VA track and store data on non-formulary drug requests?
Response: Approximately 81 percent of non-formulary drug requests are approved. PBM does not track reasons for the non-approval of requests, however, a
typical reason is due to clinicians not being aware of a suitable formulary alternative, particularly in the situation of medical trainees. Other common reasons include requests for off-label indications where there is no evidence to support safety
and efficacy for the intended indication, and indications falling outside of VHAs evidence-based clinical criteria for use. Clinicians are able to ask for adjudication of
any denial, if they disagree with the initial non-approval of the drug. PBM does
track and store data regarding the number of non-formulary drug requests received,
approved and denied, and the average process time for adjudicating the requests.
Question 4: In 2000, a report by the Institute of Medicine found that the VAs
national formulary lacked essential systems to assure that new drugs are expeditiously reviewed. Please discuss the steps that the VA has taken to address this
deficiency.
Response: At the time the Institute of Medicine (IOM) conducted its review of
the VA National Formulary, the addition of new drugs to the VANF was governed
by VHA Directive 97047 VA National Formulary Policy. Paragraph 2.d. of this
policy stated, PBM Formulary recommendations will be based on a review of new
drug products approved by the Food and Drug Administration (FDA) and recommendations by VISN formulary committees. For a new drug product to be considered for addition to the Formulary, it must be on the market for a minimum of 1
year. Exceptions can be made if the FDA designates the product as a unique therapeutic entity (FDA designation of 1P). This policy was instituted as a safety precaution because many new drugs were being fast tracked through the review process and adequate clinical trials, in our patient population, were not always available. This 1 year period allowed for adequate evaluation of these agents in our patient population.
Directive 97047 did not preclude VHA from reviewing new drugs expeditiously;
it only prevented VHA from adding them to the VA National Formulary for 1-year
after they reached the market unless they were approved by the FDA with a 1P
designation. It is important to note that individual VISNs and facilities were not
held to this policy for drug formularies managed at the local and VISN levels. They
could, and did, add new drugs to VISN and facility formularies before the 1-year
waiting period. It is also important to note that not all newly approved drugs are
relevant to the VA population and would not be expected to be reviewed nor added
to the formulary. Drugs used exclusively in the pediatric population are one example where the drugs would be neither extensively reviewed nor added to the formulary.
VHA advised IOM staff at the time they began their analysis that based on PBMs
own review of existing formulary policy, it had decided to change the 1-year moratorium and eliminate that requirement from PBM policy. Although one of the hearing
panelists stated that VAs 1-year moratorium policy is still in effect, that is not the
case; it was eliminated in July 2001.
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From 2001 through 2009 all policy governing VA Formulary practice was contained in VA Manuals, VHA Directives and PBM Policies; modified to accommodate
changes. The National Formulary was a core formulary to which each VISN was
permitted to supplement with local additions.
In an effort to ensure that a travelling veteran could obtain a needed refill or renewal of a scheduled medication at any VA location, the VISN Pharmacist Executives and the Medical Advisory Panel decided to do away with VISN variation and
establish a comprehensive National Formulary; to which additions at the local level
are no longer permitted. Therefore, on February 26, 2009, VHA published a Handbook (VHA Handbook 1108.08, VHA Formulary Management Process) which provided a comprehensive document encompassing all prior policy; including changes
implemented subsequent to the IOM analysis. Note: Under each formulary process
the ability of the provider to request a medication via a Non-formulary Request
(with an approval rate of 80 percent) was available. This accounts for approximately
4 percent of total prescriptions dispensed by VHA.
Question 5: How does the VA handle issues of patient safety and prevent adverse
drug interactions for veterans who fill their prescriptions through the VA and private pharmacies?
Response: VHAs current drug-drug interaction (DDI) software package is available at the point of care to warn against potential critical and significant drug-drug
interactions when a provider enters an outpatient prescription to be filled in a VA
pharmacy. Potential interactions are communicated to prescribers as an Alert. Prescriptions obtained outside VA are recorded in the non-VA medication field in the
computerized patient record system (CPRS) as part of the medication reconciliation
process or when at the patients request, a VA prescriber writes a prescription for
the patient to fill at his or her expense at a non-VA pharmacy. The CPRS can provide order checks for medications dispensed by a VA pharmacy, or those documented as dispensed from a non-VA pharmacy when the drug is matched to VAs
national drug file. Prescribers are required to state an override reason when submitting an order containing a critical drug-drug interaction for which they receive
an Alert. Drug-drug interactions for non-VA medications are subject to additional
manual screening by a pharmacist during the final order review. Any potential
interactions identified during the final manual review are communicated to the prescriber.
Question 6: What is the VA doing to encourage medication compliance among
veterans to maximize the results of the drug therapy?
Response: Medication compliance and monitoring is performed by clinical pharmacists, nurses and providers and discussed with patients during outpatient visits.
These reviews evaluate the dose and schedule of each medication the patient is currently taking and are performed by clinicians throughout VA. Compliance is assessed by asking the patient about their medications through a series of questions
and evaluating prescription refill patterns. It is always important to ask patients
if they are having difficulty remembering to take their medications and VA believes
clinical pharmacists are integral to the healthcare team to identify these types of
barriers to compliance. For some patients, there may be an opportunity to reduce
the medication burden (i.e. polypharmacy) to increase compliance. For others with
a significant number of prescriptions, compliance may be increased through the use
of assistive devices such as pill boxes, personalized medication schedules etc., which
VA can provide.
CPRS version 26, released in May 2006, introduced new graphing features that
are available to providers. Medication compliance can be charted in a graph with
indications of prescription dispensing events, prescription days supply, and any relevant corresponding laboratory results for the patient. This allows a visual representation of when a patient can be reliably expected to have or have had a supply
of medication on-hand.
Overall, medication compliance and monitoring is assessed and monitored on an
ongoing case-by-case basis via numerous mechanisms (patient interviews, chart reviews and refill record reviews). Medication education and adherence is a shared responsibility among patients and their healthcare providers. Clinical pharmacists are
extensively trained to assist patients with medication adherence and are available
throughout VAs facilities to provide this service.
Question 7: The VAs November 2002 directive on VA National Dual Care Policy expired in July 2007. Have there been any updates to the directive? If not, are
there plans to issue an updated directive?
Response: VA reissued the directive entitled, VHA National Dual Care Policy
on August 25, 2009 (http://vaww1.va.gov/vhapublications/ViewPublication.asp?publ
ID=2058).
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level, add to information at a national level to assist in Drug Safety Risk Communications and informed decisions, and lastly, serve as a foundation for developing
national safety based Medication Use Evaluations (MUE).
Question 9: Please describe the work and role of the VA Center for Medication
Safety. For example, what are some examples of the medication safety projects that
this Center implements? How does the Center educate the field on safe and best
practices to minimize adverse drug events? What are some examples of the research
that the Center has translated into national policy?
Response: The VA Center for Medication Safety (VAMedSAFE) is a world-class
comprehensive pharmacovigilance program. Pharmacovigilance is defined as the
science of the detection, assessment, understanding and prevention of the adverse
effects of drugs. VAMedSAFE has implemented many national projects to improve
drug safety in the Veteran population. VAMedSAFE is recognized nationally for its
efforts in drug safety and as a result has entered into a collaborative agreement
with the FDA to evaluate the significance of known ADEs, and to identify and track
new and emerging drug safety issues. As such, VAMedSAFE conducts drug safety
and monitoring efforts with the rigor of a regulatory body, while maintaining the
access and utilization required for a healthcare delivery system to take necessary
action. The work of VAMedSAFE not only informs VA policy at the national level,
but has been influential in many FDA decisions, hence affecting the U.S. population
as a whole.
VAMedSAFE accomplishes its goals by evaluating preventable ADEs through the
use of active and passive surveillance techniques, providing interventions to decrease preventable ADEs through Risk Reduction programs, educating clinical staff
about medication safety best practices, advising clinical staff about emerging safety
issues through Medication Safety/Risk Communications, and conducting and promoting medication safety research. Examples of VAMedSAFE projects include:
Rapid Cycle EvaluationsThis method uses integrated clinical and administrative databases and mining of spontaneously reported ADEs (through VA
ADERS) to identify and assess the rate and risk of ADEs for specific medications. Selected examples include:
Flouroquinolones and dysglycemia
Safety of non-steroidal anti-inflammatory drugs (NSAIDs) in VA System in
regard to the risk of myocardial infarction
Risk of thiazolidinediones and cardiovascular disease
Long-acting opioids and all cause mortality (focus on methadone)
Risk Reduction ProjectsRisk Reduction is the method used by VAMedSAFE
to identify and intervene on potential ADEs. Selected examples include:
Nifedipine IR for hypertension
High dose vitamin E for cardiovascular disease prophylaxis
Glyburide use in elderly patients with renal insufficiency
Use of high dose zolpidem IR
National Medication Use Evaluations (MUEs)VAMedSAFE conducts national
MUEs to evaluate and monitor the safe and appropriate use of agents across
the VA system. Selected examples include:
Pravastatin vs FluvastatinEvaluation of safety and appropriate use following therapeutic interchange
TravoprostEvaluation of safety following a therapeutic interchange
ErythropoesisStimulating Agents (ESAs)Evaluation of appropriate monitoring to assure safe and cost-effective use of ESAs.
To minimize adverse drug events, VAMedSAFE educates the field on safe and
best practices through safety bulletins, safety information documents attached to
risk reduction efforts and continuing education programs. In FY 2009, thirty Safety
Bulletins were disseminated to the field. VAMedSAFE develops many bulletins
elaborating on or clarifying early warning communications and other warnings from
FDA; however, many safety bulletins are developed secondary to ADE signals identified through VAMedSAFEs surveillance efforts or through direct reports and concerns from the field. Selected examples include:
Safety Bulletins
Risk of Severe Hypoglycemia with Glyburide in Patients with Renal Insufficiency
Iron Dextran and the ADEs associated with the high molecular weight formulation
Concentrated opioid solutions and concentration/confusion problems
Oxybutynin and oxycodone Look-Alike Sound-Alike (LASA) errors
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examples where off-label use of medications has been associated with patient harm.
VAs guidance document gives direction for making those difficult decisions.
Question 12: It is our understanding that some VA facility directors confer prescribing authority to certain nurses, pharmacists, and physician assistants if the
state provides this authority and if it is cosigned by a medical doctor. What guidance and oversight is provided by the central VA office?
Response: Under the principle of Federal Supremacy, VHA grants the authority
to prescribe non-controlled substances to Advanced Practice Nurses, Clinical Pharmacy Specialists, and Pharmacists with direct patient care responsibilities and Physician Assistants. VHA grants the authority to prescribe controlled substances only
to those providers whose State licensure permits this practice. This may take the
form of a clinical privilege statement or a Scope of Practice, as appropriate. Privileging or scope of practice for every individual is reviewed by the relevant facility
service chief, whose recommendation is submitted to the appropriate facility-based
body. For privileges, the recommendation, along with the appointment recommendation of the Professional Standards Board (PSB) or credentialing committee (if applicable), is submitted to the medical staffs Executive Committee for review. The medical staffs Executive Committee evaluates the applicants credentials to determine
if clinical competence is adequately demonstrated to support the granting of the requested privileges. A final recommendation is then submitted to the facility Director
for approval. For scope of practice statements, the service chiefs recommendation
is submitted for final approval to the facility-based authorizing body appropriate to
each profession.
VHA has issued Directives on each of the professional groups identified in the
question that outline the approval process for prescriptive authority. These include
VHA Directive 2009014, Establishing Medication Prescribing Authority for Clinical
Pharmacy Specialists; VHA Directive 2008049, Establishing Medication Prescribing
Authority for Advanced Practice Nurses; VHA Directive 2004029, Utilization Of
Physician Assistants (PAs); and VHA Directive 2008043, Scope Of Practice For
Pharmacists With Direct Patient Care (responsibilities).
All practitioners are required to complete the standardized VHA credentialing.
Advanced Practice Nurses and Clinical Pharmacy Specialists may be granted either
clinical privileges or a Scope of Practice, as determined by their licensure and the
facility. Pharmacists with direct patient care responsibilities and Physician Assistants are granted a Scope of Practice.
Question 13: Based on the findings of the Inspector Generals June 2009 audit
reports, what steps has the VA taken to address issues identified with the management of non-controlled drugs and the CMOP contract?
Response: VHA has taken several steps to address the deficiencies identified in
the Office of the Inspector General (OIG) reports. In regard to inventory management, VHA has developed a draft directive outlining the selective monitoring of high
cost, high risk non-controlled substances at VA medical centers and it is undergoing
review and concurrence to become VHA policy. PBM has communicated all the current dispensing requirements under the draft policy to VA Chiefs of Pharmacy on
several conference calls and through e-mail notifications. VA is pursuing Information Technology solutions regarding the use of label reprints and other OIG findings/
recommendations and is exploring the ability of its Pharmaceutical Prime Vendor
to provide standardized national inventory management tools.
VAs long-term plan to address all of OIGs findings is dependent on the use of
enhanced software capabilities to support a comprehensive inventory management
system. The specifications for the enhancements were developed and submitted in
2005 to the VAs Office of Information and Technology as part of the Pharmacy ReEngineering (PRE) project. The current plan is for this functionality to be available
sometime in 2011, depending on funding and development priorities.
All CMOP contracting recommendations have been addressed. With the exception
of rewriting the CMOP software to improve inventory accountability which is expected to be completed near the end of FY 2010, all proposed actions to meet the
OIG recommendations have been completed.
Question 14: Why did the VA allow the directive on Drug Accountability Software to lapse in 2003? Are there plans for an updated directive?
Response: VHAs directive on Drug Accountability was allowed to expire primarily due to the lack of standardized automated national tools to accomplish the
requirements. Facilities reported difficulties trying to audit high cost drugs manually. They were unable to accurately reconcile inventories due to dispensing software
limitations. It is PBMs belief that a policy which cannot be implemented in the field
is not a good management practice; therefore, PBM allowed the directive to expire
with the understanding that enhanced software development was due to be implemented in 2008 as part of the PRE project.
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After the Drug Accountability policy expired, VAs Chiefs of Pharmacy were advised that although it was no longer in effect, it would be prudent for them to continue some form of drug accountability oversight, using locally developed processes
to aid in the detection of diversion of non-controlled substances. PBM recommended
that sites take steps to limit the number of storage areas for high cost drugs and
reduce inventory levels when possible.
Though VHA still lacks the tools planned for PRE, PBM supports issuing a new
directive with monitoring that can be accomplished using currently available tools.
A draft policy has been developed and is currently undergoing review for concurrence. Once PRE inventory modules are developed and implemented, VHA will revise the policy to take advantage of the enhanced software capability.
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